Published in Cataract

The Ultimate Guide to Post-Op Refraction for the TECNIS™ Family of IOLs

Sondra Black, OD

This post is sponsored by Johnson & Johnson Surgical Vision

Discover good practices for optometrists seeing post-op cataract patients, plus important considerations in premium IOL design and special refractive techniques for optimizing postoperative outcomes.

$The Ultimate Guide to Post-Op Refraction for the TECNIS™ Family of IOLs$

When I graduated from optometry school a few decades back, it was exceedingly rare for optometrists and ophthalmologists to manage a shared cataract patient together. It was typical for patients undergoing cataract surgery to have their procedures performed in a hospital or an ambulatory surgical center, with all of the preoperative and postoperative care being delivered within the surgeon’s office. If they returned to our practices at all, it was to undergo a refraction and fill their spectacle prescription after surgery. In some instances, patients resumed their trips to our offices for regular, comprehensive examinations each year, although this was rarely a guarantee, even among doctors with the best of professional relationships.

Over the years, the challenges associated with cataract surgery have changed significantly. Techniques today are faster, more refined, and more predictable in terms of outcome.¹Meanwhile, postoperative complications are arguably less common and less severe. Moreover, the variety of intraocular lens implants (IOLs) has increased considerably, to the point where cataract surgery is sometimes viewed as an extension of refractive surgery for many patients. With an overall declining number of ophthalmologists and a staggering increase in the population requiring surgical intervention,² it is now more common than ever for patients to be treated by both the referring optometrist and the cataract surgeon for care related to both surgery and post-operative care. ODs operating in this space should be prepared to assume this responsibility and educate themselves on the critical distinctions between new IOL designs and potential. Most of all, it is imperative that optometrists can perform a postoperative refraction in a manner that maximizes the visual potential of whatever IOL is selected by the patient and their respective surgeon. Obviously, optometrists who can do this are also more likely to secure the benefit of a happy patient.

In this article, I’ll discuss a few of the more recent IOLs developed by Johnson & Johnson Vision, one of the world leaders in this technology. I’ll review their advanced designs, intended purposes, unique attributes that seek to help optimize functional vision while diminishing aberrations, and the proper techniques for maximizing patient satisfaction during the postoperative period.

Cataract Statistics

The prevalence of cataracts in any practice can vary with numerous factors, including geography, population demographics, and practice setting. Overall, however, cataract extraction is the most prevalent surgical procedure of all medical subspecialties.³ According to a 2021 publication, approximately 4 million individuals undergo cataract surgery yearly in the United States,⁴ and roughly 20 million cataract procedures are performed annually worldwide.^3,4 While most of these surgeries still involve traditional monofocal IOLs, the use of multifocal, toric, and other specialty lenses – collectively called “premium IOLs” – continues to gain ground. In 2022, the premium IOL segment made up approximately 45% of the overall IOL market, and this percentage is expected to increase over the next 6 years.⁵

Pros & Cons

Premium IOLs offer numerous benefits over traditional monofocal lenses. Among other attributes, their design is intended to provide a greater level of refractive correction, including toric engineering to address higher levels of astigmatism. Additionally, multifocals are designed to help alleviate the need for presbyopia correction (spectacles or contact lenses) after surgery. Overall, premium IOLs offer reduced dependence on corrective eyewear for pseudophakic patients, along with a greater potential to enjoy an active lifestyle without the burden of corrective eyewear or contact lenses. Additionally, with better uncorrected postoperative vision there exists the potential for reduced risk of falls and other accidents related to multifocal spectacle wear for people in certain older age ranges.^6,7 Falls among older adults are responsible for $50 billion in medical costs annually and remain the primary cause of injury death among people aged 65 and older.⁸

Despite the vast array of advantages, there are some challenges posed by premium IOLs that practitioners must acknowledge. Not every patient is a suitable candidate for intraocular lenses (IOLs), similar to contact lenses. Each type of IOL has specific criteria that patients must meet to achieve optimal visual correction. If these parameters are not met, patients may experience increased aberration and distortion in their vision. Even in those situations where the parameters are adequate, patients may have unrealistic expectations of what surgery will do for them, envisioning themselves “throwing away their glasses and contact lenses forever.” The managing physicians -- optometrist and ophthalmologist -- are in the best position to communicate any limitations, providing a more pragmatic and realistic picture of what may be possible following surgery.

In addition, the unique optical aspects of premium IOLs can greatly impact the postoperative refraction procedure, requiring a different approach than most optometrists utilize in their day-to-day practice. As I’ll discuss in greater detail a bit later, in my experience, practitioners managing these patients should:

Carefully consider patients’ habitual manifest refractive status and how that may impact the correction of residual, postoperative refractive error, and;
Employ different strategies for specific premium IOLs, particularly those that offer simultaneous correction of distance and near vision.

Understanding premium specialized IOLs

Premium IOLs are specially designed to improve vision at multiple distances, reducing, or with the hope of eliminating, the need for glasses after cataract surgery. The refractive qualities, materials, and aspheric designs differ from traditional monofocal IOLs, which only provide clear vision at a single focal point, usually set for optical infinity. The research engineers at Johnson & Johnson Vision have developed an array of premium IOLs, each with unique features to serve different patient needs and address the shortcomings of traditional IOLs. The designs include:

Enhanced Monofocal: This type of IOL is intended to focus light to a single point, providing outstanding distance vision, such as while driving. It offers enhanced vision in the intermediate zone, making it easier to view objects like a computer screen. This can expand the range by an additional line of letters.⁹
Multifocal: Multifocal IOLs distribute light to both near and far focal points, providing good distance as well as intermediate visibility. Studies have shown that 81–85% of patients who receive multifocal IOLs are independent of glasses after surgery. Multifocal IOLS can be classified as bifocal, trifocal, and extended depth of focus, and some designs have a toric design.^10,11 Bifocal and trifocal designs incorporate a far and near focus, while the trifocal IOL has an additional focal point for intermediate distance.^10,11Trifocal IOL patients typically experience improved intermediate and near vision with fewer photic phenomena compared to those with monofocal and bifocal IOLs.¹²
Extended Depth of Focus (EDoF): IOLs using an EDoF design permit the elongation of entering light rays to provide a natural, continual range of vision. This type of IOL employs a very different segment than traditional multifocal IOLs to provide distance, intermediate, and functional near vision.^10,12
Full Visual Range: These IOLS provide functional and clear vision at distance, intermediate and near distances.¹⁰ The Hybrid Multifocal IOL lens design combines multifocal and extended depth of focus optics. It provides excellent vision from far to intermediate distance.¹²Accommodative IOL designs allow for a significant increase in the eye's dioptric power when the eye accommodates. While distance visual acuity and contrast sensitivity are comparable to those of monofocal intraocular lenses (IOLs), over half of the patients report experiencing halos and glare. Additionally, between 40% to 70% of patients still require reading glasses.¹¹

The “Trade-Off”

If these premium IOLs sound too good to be true, there is a downside. One important consideration that both patients and practitioners need to understand and reconcile is the potential impact of media irregularities on premium IOLs. Because the optical design is so specific, alterations in any of the other refractive surfaces of the eye can greatly impact performance. For example, patients with preexisting dry eye disease are more likely to have a large amount of higher order aberrations than those with a normal tear film, due to the amount of light scatter passing through the cornea.¹³ If these aberrations are not identified and corrected during presurgical planning¹⁴, it can lead to inaccurate lens calculations, potentially resulting in an increased risk of postoperative complications as well as diminished potential for overall patient satisfaction.^15-17 Of course, the cornea is not the only aspect of the eye that can present media irregularities. Some vitreous floaters may also be associated with greater visual disturbances after premium IOL implantation, especially in those with high levels of myopia. Again, this should be identified during the preoperative examination, and taken into consideration when determining the ideal lens design for a particular candidate. At the very least, patients with such media irregularities must be educated as to the potential for diminished outcomes and expectations.

The TECNIS™ Family of IOLs

Within the Johnson & Johnson portfolio of premium IOLs, three products warrant discussion. Each distinct product shares the TECNIS™ platform, proven over the last 20 years. This innovative platform has IOLs that address spherical and chromatic aberration providing better quality of vision.¹⁸ It also offers the advantage of sustained optical clarity and stability.^19-21 Moreover, each of these implants speaks to a distinct patient population with different visual needs and priorities. In this next section, I’ll discuss some of the finer points associated with these IOLs, including their unique characteristics, important patient selection features, and key post-op considerations. A summary of these characteristics and features is included in Table 1, while a summary of postoperative considerations may be found in Table 2. It should also be noted that all of the following IOLs are available in a toric version (i.e., Toric II platform) as well, for those patients with levels of astigmatism that warrant surgical correction.

*The TECNIS Eyhance™ IOLs are designed to slightly extend the depth of focus compared to the TECNIS 1-Piece IOL, Model ZCB00 as measured in bench testing.

**Continuous 20/25 or better

^#Based on pre-clinical bench testing

† Compared to PanOptix^® based on bench testing

^¶ Compared to TECNIS Synergy™ and TECNIS™ Multifocal IOLs based on pre-clinical bench testing.

TECNIS Eyhance™ IOL

The TECNIS Eyhance™ was designed to slightly extend the depth of focus. It has been described as a “distance plus” design, providing a continuous increase in power from the lens edge to its center, offering a slightly extended depth of focus when set to achieve a plano distance Rx.^31,32 Additionally, as compared to the leading monofocal IOL,^☨ the TECNIS Eyhance™ is capable of delivering better image contrast in low light.²³

^☨Best contrast and low light performance day and night vs Acrysof^® IQ (SN60WF), Clareon^® (CNA0T0), enVista^® (MX60E) and Acrysof^® (SA60AT). Registered trademarks are the property of the respective manufacturers.

*Data on File, Johnson & Johnson Surgical Vision, Inc. 2021 DOF2021CT4002

*Based on bench testing. Data on File CT4002, MTF testing using ACE model, white light at 3 and 5 mm pupil

There are two important considerations for managing patients with the TECNIS Eyhance™ IOL. First, always inform patients they will still need to wear spectacles for near distances, particularly when engaging in highly detailed tasks like reading or using a smartphone. However, reassure them that they may gain some increased range for intermediate tasks, e.g., gazing at the computer screen or selecting items from the shelf at the grocery store. Second, due to the elongated focus of the TECNIS Eyhance™, the post-op refraction needs to be performed with care using the maximum plus refraction technique (i.e., “pushing plus”).

TECNIS Symfony™ OptiBlue™ IOL with InteliLight™

The TECNIS Symfony™ OptiBlue™ IOL falls within the category of EDoF lenses. It provides a continuous range of vision while yielding excellent distance and intermediate viewing, as well as functional near acuity.^25,33 TECNIS Symfony™ OptiBlue™ is one of the presbyopia-correcting lenses in the TECNIS™ family of IOLs that incorporates InteliLight™ technology, which leverages 3 distinct features:

Violet-Light Filter - Violet light represents the shortest wavelengths of light within the visible spectrum, occupying that portion between 380 and 435 nm. According to a variety of sources, these very high frequency wavelengths are responsible for producing the greatest amount of light scatter.^34-36Hence, the violet-light filter within the TECNIS Symfony™ OptiBlue™ IOL serves to mitigate halos, glare, and starbursts, the primary visual disturbances that negatively impact nighttime driving.³⁷
High-resolution lathing process - An echellete is a type of diffraction grating characterized by relatively low groove density, but employing a groove shape that is optimized for use at high incidence angles. By combining an aspheric anterior surface and a posterior diffractive surface, EDoF lenses create a diffractive pattern that elongates a single focal point; this extended focus allows for nearly all light to be transmitted through the IOL.³⁸ Unfortunately, this design can sometimes be associated with irritating visual aberrations under low-light conditions.³⁹ The unique diffractive lens technology inherent to TECNIS Symfony™ OptiBlue™ is engineered to transmit light over a range of distances for sharp, clear vision.^19,40 The echelette design helps to improve the reduction of light scatter & halo intensity.³⁹
Achromatic Technology - The achromatic technology within the InteliLight™ platform is intended to further enhance image contrast and correct chromatic aberrations, resulting in a sharp image at near, intermediate, and distant ranges. Like the violet-light filter, it is particularly beneficial under low light conditions, although the contrast enhancement can be appreciated both during the day and at night. This particular feature is especially important as reduced contrast perception has been reported to increase the risk of falls in elderly individuals.⁴¹

With these three proprietary aspects of InteliLight™ technology, the TECNIS Symfony™ OptiBlue™ provides a wider range of uninterrupted vision and superior performance across every distance than Acrysof^® IQ Vivity^® IOLs, and better image contrast day and night, than competitor IOLs.^*24,25,26

*vs. AcrySof^® ReSTOR^® +2.5 Dand AcrySof^® IQ Vivity^®

Figure 1. The proprietary aspects of InteliLight™ technology

In addition to these features, the TECNIS Symfony™ OptiBlue™ is – like all lenses in the TECNIS™ family of IOLs — specifically designed to function independently of pupil size under all lighting conditions (i.e., pupil-independent).⁴²Pupil size can be a determining factor for some multifocal IOLs, especially those that employ a center-near design; as the pupils constrict with the near reflex, the effective power of the lens is increased through the central region of the lens. Such devices are said to be pupil-dependent. However, with the TECNIS™ family of IOLs, even patients with relatively large pupils can enjoy crisp, high-quality vision under mesopic and scotopic conditions.⁴²

When comanaging patients with the TECNIS Symfony™ OptiBlue™ IOL, it is important to discuss its potential limitations to set reasonable expectations as some patients may need to wear corrective lenses for some activities.²⁷ More to the point, while it may be quite easy for postoperative patients to see their cell phone or tablet without correction, additional plus power may be required to read fine print, such as the writing on medication bottles or ingredient labels on packaged foods. Also, while the TECNIS Symfony™ OptiBlue™ has numerous design features to mitigate low light aberrations, they should understand that these may still be encountered in a small percentage of patients.⁴³Specifically, glare and visual disturbances (i.e., spider web-like halo) may still occur under low-light conditions.²² These often diminish over time, however, as the process of neural adaptation ensues. I like to tell patients that it takes some time for their brains to “get used to” the new optical system within their eyes.

TECNIS Odyssey™ IOL

The TECNIS Odyssey™ represents the newest technology from Johnson & Johnson Vision and is unique from other lenses with comparable capabilities. Described as "a full visual range" IOL,^§,44it utilizes characteristics of both multifocal and EDoF design to provide a continuous, full range of vision from distance to near.^§45 Incorporating a low scatter diffractive surface and pupil-independent optics, the TECNIS Odyssey™ IOL is ideal for patients who wish to maximize their spectacle independence,^||,27 and achieve a low incidence of bothersome visual disturbances.⁴⁶In this way, the TECNIS Odyssey™ provides greater tolerance to residual refractive error,^¶,30 as measured by defocus visual acuity over a full diopter (i.e., from +0.50 to -0.50 with the potential for 20/25 acuity). Like the TECNIS Symfony™ OptiBlue™, this IOL affords patients low potential incidents for dysphotopsias (i.e., night vision symptoms), as well as best-in-category contrast and excellent low-light performance.^28,29

^§ Continuous 20/25 or better

^|| Individual results will vary. Some TECNIS Odyssey™ patients may require spectacles post-surgery.

^¶ Compared to TECNIS Synergy™ and TECNIS™ Multifocal IOLs based on pre-clinical bench testing.

Image courtesy of Johnson & Johnson

Figure 2. The low scatter diffractive surface of the TECNIS Odyssey™ IOL

There are limitations to the TECNIS Odyssey™ IOL that must be acknowledged and understood by potential candidates. Notably, patients with a predicted postoperative astigmatism greater than 1.00 diopter may not be suitable candidates for this IOL. These patients may not experience the benefits of reduced spectacle wear or improved near and intermediate vision that patients with lower predicted postoperative astigmatism may see.⁴⁵

Collaborative care and the OD’s role

Preoperative counseling and evaluation

The OD’s role in collaborative care often involves, as much as anything else, learning about the patient and their daily activities. While we understand the importance of efficiency in practice, we must not overlook the significance of conversing with the patient when determining the best options for surgical correction following cataract extraction. As illustrated previously, we need to understand our patients’ visual needs, priorities, and typical environment to make the best recommendations for an optical correction system that will likely be with them for the rest of their lives.

Discussing the basic lens options and attributes of premium IOLs may seem overwhelming at first for both the doctor and the patient. Our job is to provide consistently accurate and unbiased information while gently guiding the patient to the best possible treatment modality. In addition to gaining critical insights about the patient, this also will ultimately help them to feel less overwhelmed when they finally reach the surgeon’s office. Of course, we as optometrists understand that the final decision of which IOL is most suitable for a given situation is ultimately the surgeon’s, and we must remind our patients of this fact. However, this decision will be based on collective input from discussions with the candidate as well as input from the referring doctor. Hence, the better we educate our patients, the easier it will be for them to work successfully with the surgeon. Additionally, this time allows us to set realistic goals and expectations for postoperative outcomes.

In terms of preoperative management, candidates for the

TECNIS Symfony™ OptiBlue™ and especially the TECNIS Odyssey™ are at particular risk for aberrations secondary to ocular surface irregularities, including dry eye disease. For patients who express interest in these lenses, be sure to optimize the ocular surface and treat any symptomatic disease, including meibomian gland dysfunction and/or anterior blepharitis before and after surgery, as indicated.

Postoperative counseling and evaluation

Each surgeon and co-managing optometrist may have different protocols for surgical follow-up. In most uncomplicated cases, there are at least 4 visits to be expected: 1 day, 1 week, 1 month, and 3 months post-op. Many surgeons still prefer to conduct the 1-day visit within their offices, though this is by no means a necessity. A typical postoperative protocol for the remaining standard visits is summarized in Table 2.

Regardless of the follow-up protocol, one thing that must be stressed early in the postoperative period with all presbyopia-correcting IOLs is the necessity of neural adaptation. Because the image that is transmitted through this complex new optical system is unlike anything they may have experienced previously, patients need to be informed and reassured regarding their brain’s ability to process this information, and the importance of providing adequate time in which to achieve this adaptation. While this topic may not be a conversation we are used to initiating with traditional, monofocal IOLs, it is nonetheless a critical element for achieving success and creating a positive experience for the patient.

Special Refractive Techniques for Premium IOLs

Patients with premium IOLs require a more specialized approach in terms of postoperative refraction than those with standard monofocal IOLs or phakic individuals. Standard refractive techniques tend to yield inaccurate results due to the unique optical properties of these lenses. First and foremost, clinicians and staff must avoid relying on the autorefractor for a starting point in those with premium IOLs. Instead, assess patients objectively using a retinoscope, or initiate the subjective refraction starting from plano.

Always isolate the postsurgical eye and perform a monocular refraction; this is particularly important when evaluating the initial eye, as the optics of the fellow eye will be quite disparate. Permitting the patient to give responses based on binocular viewing will almost certainly lead to visual confusion and frustration.

Once the distance correction has been established, assess visual acuity using the smallest line that can be seen by the patient without straining. This is an important consideration that can help to diminish the potential for overminusing due to the pinhole effect. It is critical to “push plus”; concerning the TECNIS™ family of IOLs, this technique is most important for the

TECNIS Eyhance™ and TECNIS Symfony™ OptiBlue™ lenses, and somewhat less crucial with

TECNIS Odyssey™. To execute this procedure, add +1.00 D to the manifest, or add plus in quarter diopter steps until the patient can no longer see 2-3 lines higher than the best VA obtained previously (e.g., the 20/40 line, if VA with the manifest was 20/20 at distance). Next, slowly decrease plus / increase minus in -0.25 D steps, performing repeated VA checks with each successive change. “Maximum Plus” will have been achieved when ALL letters on the line can be read clearly for the first time. Note that this may not necessarily be the point at which patients say the letters are clearest, but bear in mind that with IOLs that facilitate simultaneous vision at multiple foci, overcorrection at distance will significantly impact the functional acuity attainable at the intermediate and near ranges.

Conclusion

While cataract surgery is a specific realm of ophthalmology, optometrists play an important role in the education, selection, and utilization of IOLs in their patients. As the number of ophthalmologists decreases and the need for cataract surgery in our population increases, optometry finds itself in a unique position to fill in the gaps by assuming many of the responsibilities previously performed solely by ophthalmologists and their staff. This growth in scope of practice is good not only for our profession, but also for our financial success, and it allows us to serve as part of a team that is destined to improve our patients’ quality of life. Optometrists must meet this challenge by first educating themselves, then educating patients, and finally by taking the lead proactively regarding cataract comanagement.

Johnson & Johnson Surgical Vision, Inc., and its affiliates and subsidiaries (J&J) do not provide medical advice and the information contained herein is offered for informational purposes only. This post is not intended to be construed as medical advice or practice management and is no substitute for proper medical training or consulting with a license eye care professional. Please refer to each products directions for use for full indication and safety information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS ODYSSEY™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DRN00V AND TECNIS ODYSSEY™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELS DRT150, DRT225, DRT300, DRT375

Rx Only

INDICATIONS FOR USE:

The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ Toric II IOLs that are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Odyssey™ IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

PRECAUTIONS:

This is a single use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects.

Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C).

Do not autoclave the delivery system.

Do not advance the lens unless ready for lens implantation.

The contents are sterile unless the package is opened or damaged.

The recommended temperature for implanting the lens is at least 63°F (17°C).

The use of Balanced Salt Solution or Ophthalmic Viscosurgical Devices (OVDs), is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of OVDs. The use of balanced salt solution with additives has not been studied for this product.

Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/ or the lens may have been compromised.

When performing refraction in patients implanted with the lens, interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended.

The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design.

Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.

The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.

Care should be taken to achieve centration of the intraocular lens in the capsular bag.

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of the device and provide them a copy of the patient information brochure.

Children under the age of 2 years are not suitable candidates for intraocular lenses.

The lens should not be placed in the ciliary sulcus.

Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the toric lens with the intended axis of placement.

The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). The PCA is based on an algorithm that combines published literature (Koch, et al., 2012) and a retrospective analysis of data from a TECNIS™ Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS™ Toric IOL U.S. IDE study and may yield results different from those in the TECNIS Odyssey™ Toric II IOL labeling. Please refer to the TECNIS™ Toric IOL Calculator user manual for more information.

The use of methods other than the TECNIS™ Toric IOL Calculator to select cylinder power and appropriate axis of implantation were not assessed in the TECNIS™ Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the toric lens.

All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon's estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of TECNIS Odyssey™ Toric II IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism <1.0 diopter has not been demonstrated.

Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Odyssey™ and TECNIS Odyssey™ Toric II IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism.

All corneal incisions were placed temporally in the TECNIS™ Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS™ Toric IOL. Note that the TECNIS™ Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

Do not reuse.

The safety and effectiveness of the TECNIS Odyssey™ IOL and the TECNIS Odyssey™ Toric II IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions, such as pupil abnormalities, prior corneal refractive or intraocular surgery, acute or chronic ophthalmic diseases or conditions (see below for examples).

Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions.

Before Surgery

Pupil abnormalities

Prior corneal refractive or intraocular surgery

Choroidal hemorrhage

Chronic severe uveitis

Concomitant severe eye disease

Extremely shallow anterior chamber

Medically uncontrolled glaucoma

Microphthalmos

Non-age-related cataract

Proliferative diabetic retinopathy (severe)

Severe corneal dystrophy

Severe optic nerve atrophy

Irregular corneal astigmatism

Amblyopia

Macular disease

Pregnancy

During Surgery

Excessive vitreous loss

Non-circular capsulotomy/capsulorhexis

The presence of radial tears known or suspected at the time of surgery

Situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed by direct visualization

Cataract extraction by techniques other than phacoemulsification or liquefaction

Capsular rupture

Significant anterior chamber hyphema

Uncontrollable positive intraocular pressure

Zonular damage

Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. Adverse events that may be associated with use of the device include: IOL dislocation, tilt or decentration, visual symptoms requiring lens removal, residual refractive error, secondary surgical intervention (including IOL repositioning or removal). Do not leave the lens in a folded position more than 10

minutes. When the delivery system is used improperly, the lens may not be delivered properly, (i.e., haptics may be broken). Please refer to the specific instructions for use provided.

WARNINGS:

Intraocular lenses may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the eyesight of patients with:

Recurrent severe anterior or posterior segment inflammation of unknown etiology

Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens

Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss)

Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible

Risk of damage to the endothelium during implantation

Suspected microbial infection

Congenital bilateral cataracts

Previous history of, or a predisposition to, retinal detachment

Potentially good vision in only one eye

Medically uncontrollable glaucoma

Corneal endothelial dystrophy

Proliferative diabetic retinopathy

Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starbursts or glare around lights), which may be expected in nighttime or poor visibility conditions. Patients may perceive these visual effects as bothersome, which, on rare occasions, may be significant enough for the patient to request removal of the IOL.

A reduction in contrast sensitivity compared to an aspheric monofocal IOL may be experienced by some patients under certain conditions. The physician should carefully weigh the potential risks and benefits for each patient, with special consideration of potential visual problems before implanting the lens in patients including those with macular disease, amblyopia, corneal irregularities, or other ocular disease that may cause present or future reduction in acuity or contrast sensitivity, and should fully inform the patient of the potential for reduced contrast sensitivity and to exercise caution when driving at night or in poor visibility conditions after implantation.

Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully benefit in terms of reducing spectacle wear.

Rotation of the toric lens from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design.

Do not use if the cartridge of the delivery system is cracked or split prior to implantation.

Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system.

During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens.

After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge.

The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination.

The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

INDICATION AND IMPORTANT SAFETY INFORMATION for the TECNIS Symfony™
OptiBlue™ Extended Range of Vision IOL with TECNIS SIMPLICITY™ Delivery System and TECNIS Symfony™ Toric II OptiBlue™ Extended Range of Vision IOL with TECNIS SIMPLICITY™ Delivery System

Rx Only

INDICATIONS:

The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS
Symfony™ OptiBlue™ Extended Range of Vision IOL, which is indicated for primary
implantation for the visual correction of aphakia, in adult patients, with less than 1 diopter of pre-
existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates
the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric
monofocal IOL, the lens provides improved intermediate and near visual acuity, while
maintaining comparable distance visual acuity. The lens is intended for capsular bag placement
only.
The TECNIS SIMPLICITY ™ Delivery System is used to fold and assist in inserting the TECNIS
Symfony™ Toric II OptiBlue™ Extended Range of Vision IOLs that are indicated for primary
implantation for the visual correction of aphakia and for reduction of residual refractive
astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal
astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of
presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL,
the lens provides improved intermediate and near visual acuity, while maintaining comparable
distance visual acuity. The lenses are intended for capsular bag placement only.
WARNINGS:
Physicians considering lens implantation under any of the following circumstances should weigh
the potential risk/benefit ratio:
1. Patients with any of the following conditions may not be suitable candidates for an intraocular
lens because the lens may exacerbate an existing condition, may interfere with diagnosis or
treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight:
a) Patients with recurrent severe anterior or posterior segment inflammation or uveitis of
unknown etiology, or any disease producing an inflammatory reaction in the eye.
b) Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat
posterior segment diseases.
c) Surgical difficulties at the time of cataract extraction, which may increase the potential for
complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure
or significant vitreous prolapse or loss).
d) A compromised eye due to previous trauma or developmental defects in which appropriate
support of the IOL is not possible.
e) Circumstances that would result in damage to the endothelium during implantation.
f) Suspected microbial infection.

g) Patients in whom neither the posterior capsule nor the zonules are intact enough to provide
support for the IOL.
h) Children under the age of 2 years are not suitable candidates for intraocular lenses.
i) Congenital bilateral cataracts.
j) Previous history of, or a predisposition to, retinal detachment.
k) Patients with only one good eye with potentially good vision.
l) Medically uncontrollable glaucoma.
m) Corneal endothelial dystrophy.
n) Proliferative diabetic retinopathy.
2. The TECNIS Symfony™ OptiBlue™ IOL should be placed entirely in the capsular bag and
should not be placed in the ciliary sulcus.
3. The TECNIS Symfony™ OptiBlue™ IOL may cause a reduction in contrast sensitivity under
certain conditions, compared to an aspheric monofocal IOL. The physician should carefully
weigh the potential risks and benefits for each patient, and should fully inform the patient of the
potential for reduced contrast sensitivity before implanting the lens in patients. Special
consideration of potential visual problems should be made before implanting the lens in patients
with macular disease, amblyopia, corneal irregularities, or other ocular disease which may
cause present or future reduction in acuity or contrast sensitivity, and patients implanted with the
lens should be informed to exercise special caution when driving at night or in poor visibility
conditions.
4. Some visual effects associated with the TECNIS Symfony™ OptiBlue™ IOL may be
expected due to the lens design that delivers elongation of focus. These may include a
perception of halos, glare, or starbursts around lights under nighttime conditions. The
experience of these phenomena will be bothersome or very bothersome in some people,
particularly in low-illumination conditions. On rare occasions, these visual effects may be
significant enough that the patient may request removal of the IOL.
5. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be
suitable candidates for implantation with the TECNIS Symfony™ OptiBlue™ IOL, Model
DXR00V, and the TECNIS Symfony™ Toric II OptiBlue™ IOLs, Models DXW150, DXW225,
DXW300, and DXW375, as they may not obtain the benefits of reduced spectacle wear or
improved intermediate and near vision seen in patients with lower astigmatism.
6. The effectiveness of TECNIS Symfony™ Toric II OptiBlue™ IOLs in reducing postoperative
residual astigmatism in patients with preoperative corneal astigmatism < 1.0 diopter has not
been demonstrated.
7. Rotation of TECNIS Symfony™ Toric II OptiBlue™ IOLs away from their intended axis can
reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative
refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens
encapsulation.

8. Johnson & Johnson Surgical Vision, Inc. IOLs are single-use devices only. Do not reuse this
IOL.
9. Do not attempt to disassemble, modify or alter the delivery system or any of its components,
as this can significantly affect the function and/or structural integrity of the design.
10. Do not use if the cartridge of the delivery system is cracked or split prior to implantation.
11. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the
delivery system.
12. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second)
during initial IOL advancement. Doing so may result in improper folding of the lens.
13. Do not advance the IOL from the Holding Position (Figure 11) prior to fully hydrating the
system. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to
prevent sticking and a potential scratch or crack to the IOL.
14. Do not advance the IOL from the Holding Position until ready for implantation. Interruptions
during delivery may result in the IOL being scratched or cracked or stuck in the cartridge.
Discard the device if the IOL has been advanced past the Holding Position but not delivered
within 60 seconds.
15. The lens and delivery system should be discarded if the lens has been folded within the
cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the
cartridge.
16. Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with
instructions for use and handling to minimize exposure to conditions which may compromise the
product, patient, or the user. When used according to the directions for use, the delivery system
minimizes the risk of infection and/or inflammation associated with contamination.
17. The reuse/ resterilization /reprocessing of Johnson & Johnson Surgical Vision, Inc. single-
use devices may result in physical damage to the medical device, failure of the medical device
to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness
due to product contamination, transmission of infection, and lack of product sterility.
PRECAUTIONS:
1. This is a single-use device. Do not resterilize the lens or the delivery system. Most sterilizers
are not equipped to sterilize the soft acrylic material and the preloaded inserter material without
producing undesirable side effects.
2. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F
(35°C).
3. Do not autoclave the delivery system.
4. Do not advance the lens unless ready for lens implantation.
5. The contents are sterile unless the package is opened or damaged.
6. The recommended temperature for implanting the lens is at least 63°F (17°C).

7. The use of balanced salt solution or viscoelastics is required when using the delivery system.
For optimal performance when using OVD, use the HEALON™ family of viscoelastics. The use
of balanced salt solution with additives has not been studied for this product.
8. Do not use if the delivery system has been dropped or if any part was inadvertently struck
while outside the shipping box. The sterility of the delivery system and/or the lens may have
been compromised.
9. Prior to surgery, the surgeon must inform prospective patients of the possible risks and
benefits associated with the use of this device and provide a copy of the patient information
brochure to the patient.
10. When performing refraction in patients implanted with the TECNIS Symfony™ OptiBlue™
IOL, interpret results with caution when using autorefractors or wavefront aberrometers that
utilize infrared light, or when performing a duochrome test. Confirmation of refraction with
maximum plus manifest refraction technique is recommended.
11. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected
by the TECNIS Symfony™ OptiBlue™ IOL optical design.
12. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens
wearers, surgeons should establish corneal stability without contact lenses prior to determining
IOL power.
13. The surgeon should target emmetropia as this lens is designed for optimum visual
performance when emmetropia is achieved.
14. Care should be taken to achieve IOL centration, as lens decentration may result in a patient
experiencing visual disturbances under certain lighting conditions.
15. Do not leave the lens in a folded position more than 10 minutes.
16. When the delivery system is used improperly, the lens may not be delivered properly, (i.e.,
haptics may be broken). Please refer to the specific instructions for use provided.
17. The safety and effectiveness of TECNIS Symfony™ OptiBlue™ IOLs have not been
substantiated in patients with preexisting ocular conditions and intraoperative complications
(see below for examples). Careful preoperative evaluation and sound clinical judgment should
be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with
one or more of these conditions:
Before Surgery
• Pupil abnormalities
• Prior corneal refractive or intraocular surgery
• Choroidal hemorrhage
• Chronic severe uveitis
• Concomitant severe eye disease
• Extremely shallow anterior chamber

• Medically uncontrolled glaucoma
• Microphthalmos
• Non-age-related cataract
• Proliferative diabetic retinopathy (severe)
• Severe corneal dystrophy
• Severe optic nerve atrophy
• Irregular corneal astigmatism
• Amblyopia
• Macular disease
• Pregnancy
During Surgery
• Excessive vitreous loss
• Non-circular capsulotomy/capsulorhexis
• The presence of radial tears known or suspected at the time of surgery
• Situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed
by direct visualization
• Cataract extraction by techniques other than phacoemulsification or liquefaction
• Capsular rupture
• Significant anterior chamber hyphema
• Uncontrollable positive intraocular pressure
• Zonular damage
18. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the
case. Residual viscoelastic and/or overinflation of the capsular bag may allow the lens to rotate,
causing misalignment of the TECNIS Symfony™ Toric II OptiBlue™ IOL with the intended axis
of placement.
19. The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal
astigmatism (PCA). The PCA is based on an algorithm that combines published literature (Koch
et.al, 2012) and a retrospective analysis of data from a TECNIS™ Toric multi-center clinical
study. The PCA algorithm for the selection of appropriate cylinder power and axis of
implantation was not assessed in a prospective clinical study and may yield results different
from those in the TECNIS™ Toric intraocular lens labeling. Please refer to the Johnson &
Johnson Surgical Vision, Inc. Toric Calculator user manual for more information.
20. The use of methods other than the TECNIS™ Toric Calculator to select cylinder power and
appropriate axis of implantation were not assessed in the parent TECNIS™ Toric IOL U.S. IDE

study and may not yield similar results. Accurate keratometry and biometry, in addition to the
use of the TECNIS™ Toric Calculator (www.TecnisToricCalc.com), are recommended to achieve
optimal visual outcomes for the TECNIS Symfony™ Toric II IOL.
21. All preoperative surgical parameters are important when choosing a TECNIS Symfony™
Toric II OptiBlue™ IOL for implantation, including preoperative keratometric cylinder (magnitude
and axis), incision location, surgeons estimated surgically induced astigmatism (SIA) and
biometry. Variability in any of the preoperative measurements can influence patient outcomes,
and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism.
22. All corneal incisions were placed temporally in the parent TECNIS™ Toric IOL U.S. IDE
study. If the surgeon chooses to place the incision at a different location, outcomes may be
different from those obtained in the clinical study for the parent TECNIS™ Toric IOL. Note that
the TECNIS™ Toric Calculator incorporates the surgeon’s estimated SIA and incision location
when providing IOL options.
23. Potential adverse effects (e.g., complications) associated with the use of the device include
the following:
• Infection (endophthalmitis)
• Hypopyon
• IOL dislocation
• Cystoid macular edema
• Corneal edema
• Pupillary block
• Iritis
• Retinal detachment/tear
• Raised IOP requiring treatment
• Visual symptoms requiring lens removal
• Tilt and decentration requiring repositioning
• Residual refractive error resulting in secondary intervention.
Secondary surgical interventions include, but are not limited to:
• Lens repositioning (due to decentration, rotation, subluxation, etc.)
• Lens replacement
• Vitreous aspirations or iridectomy for pupillary block
• Wound leak repair
• Retinal detachment repair
• Corneal transplant

• Lens replacement due to refractive error
• Unacceptable optical/visual symptoms
• Severe inflammation.
SERIOUS ADVERSE EVENTS
The most frequently reported serious adverse events during the clinical trial of the TECNIS
Symfony™ lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention
(treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No lens-
related adverse events occurred during the trial. Overall, 2.7% (4/148) of TECNIS Symfony™
subjects experienced serious adverse events during the study and 0% (0/148) experienced
device-related or unanticipated events.
ATTENTION
Reference the Directions for Use labeling for a complete listing of indications and important
safety information.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance™ and TECNIS Eyhance™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery System

Rx Only

INDICATIONS FOR USE

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance™ IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance™ Toric II IOLs for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight. These conditions are not specific to the design of the lens and are attributed to cataract surgery and IOL implantation in general: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye, b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, c. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), d. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible, e. Circumstances that would result in damage to the endothelium during implantation, f. Suspected microbial infection, g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL, h. Congenital bilateral cataracts, i. Previous history of, or a predisposition to, retinal detachment, j. Patients with only one good eye with potentially good vision, k. Medically uncontrollable glaucoma, l. Corneal endothelial dystrophy, m. Proliferative diabetic retinopathy, n. Children under the age of 2 years are not suitable candidates for intraocular lenses, The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus, Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The clinical study for the TECNIS™ Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. Rotation of the toric lens from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

PRECAUTIONS

The safety and effectiveness of the TECNIS Eyhance™ IOL and TECNIS Eyhance™ Toric II IOL has not been substantiated in clinical trials. The effects of the TECNIS Eyhance™ IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. MTF testing of the TECNIS Eyhance™ IOL may aid the Surgeon in understanding the theoretical image quality expected with the TECNIS Eyhance™ IOL compared to other JJSV monofocal IOLs (AAB00 and ZCB00). However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the TECNIS Eyhance™ IOL against the potential for risks and the lack of clinical data to characterize the impact of the TECNIS Eyhance™ IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.). Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Some autorefractors utilize only the central part of the IOL to calculate the refraction of the eye and that is the region where the TECNIS Eyhance™ deviates from the monofocal design which could result in a wrong estimation of the refraction. Manual refraction with maximum plus technique is strongly recommended. Recent contact lens usage may affect the patient's refraction; therefore, for patients who wear contact lenses, surgeons should establish corneal stability without contact lenses prior to determining IOL power. The lens is designed for optimum visual performance when emmetropia is targeted. This is a single use device, do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the delivery system. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balanced salt solution or viscoelastics is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of viscoelastics. The use of balanced salt solution with additives has not been studied for this product. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised. Do not leave the lens in a folded position more than 10 minutes. When the delivery system is used improperly, the lens may not be delivered properly (i.e., haptics may be broken). Please refer to the specific instructions for use provided. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS Eyhance™ Toric II IOL with the intended axis of placement. The use of methods other than the TECNIS™ Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study for the TECNIS™ Toric 1-Piece IOLs. and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the TECNIS Eyhance™ Toric II IOLs have not been substantiated in patients with the following preexisting ocular conditions and intraoperative complications (see below). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Before Surgery: Choroidal hemorrhage, Chronic severe uveitis, Concomitant severe eye disease, Extremely shallow anterior chamber, Medically uncontrolled glaucoma, Microphthalmos, Non-age-related cataract, Proliferative diabetic retinopathy (severe), Severe corneal dystrophy, Severe optic nerve atrophy, Irregular corneal astigmatism. During Surgery: Excessive vitreous loss, Capsulotomy by any technique other than a circular tear, The presence of radial tears known or suspected at the time of surgery, Situations in which the integrity of the circular tear cannot be confirmed by direct visualization, Cataract extraction by techniques other than phacoemulsification or liquefaction, Situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.), Capsular rupture, Significant anterior chamber hyphema, Uncontrollable positive intraocular pressure, Zonular damage. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS™ Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS™ Toric intraocular lens labeling. Please refer to the Johnson & Johnson Surgical Vision, Inc. Toric Calculator user manual for more information. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes, and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study for the TECNIS™ Toric 1-Piece IOLs. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS™ Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent iritis, persistent raised IOP (intraocular pressure) requiring treatment, acute corneal decompensation, secondary surgical intervention (including implant repositioning, removal, or other surgical procedure) and any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. The most frequently reported cumulative adverse event that occurred during the SENSAR™ 1-Piece IOL clinical trial was cystoid macular edema which occurred at a rate of 3.3%. Other reported events included secondary surgical intervention (pars plana vitrectomy with membrane peel) which occurred at a rate of 0.8% and lens exchange (torn haptic related to improper loading technique) which occurred at a rate of 0.8%. The most frequently reported cumulative adverse event that occurred during the TECNIS™ Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

References

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MarketScope. 2021 IOL Market Report. 2021.
Kauh CY, Blachley TS, Lichter PR, et al. Geographic variation in the rate and timing of cataract surgery among US communities. JAMA Ophthalmol. 2016;134:267–276. 10.1001/jamaophthalmol.2015.5322.
Rossi T, Romano MR, Iannetta D, et al. Cataract surgery practice patterns worldwide: a survey. BMJ Open Ophthalmol. 2021;6(1):e000464. doi: 10.1136/bmjophth-2020-000464.
U.S. intraocular Lens Market Share & Forecast [2030]. Fortune Business Insights; May 2024. https://www.fortunebusinessinsights.com/u-s-intraocular-lens-iol-market-107513. Accessed May 29, 2024.
Haran MJ, Lord SR, Cameron ID, et al. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial. BMC Geriatr. 2009;9:10. doi: 10.1186/1471-2318-9-10.
Elliott DB. The Glenn A. Fry award lecture 2013: blurred vision, spectacle correction, and falls in older adults. Optom Vis Sci. 2014;91(6):593-601. doi: 10.1097/OPX.0000000000000268.
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Freeman, B. 2024 MarketScope IOL Report. https://www.market-scope.com/pages/reports/437/2024-iol-market-report-global-analysis-for-2023-to-2029-march-2024#reports. Published March 2024
2025REF4224 ISO 11979-7 Fifth edition 2024-01 Ophthalmic Implants
Miret JJ, Camps VJ, García C. et al. Analysis and comparison of monofocal, extended depth of focus and trifocal intraocular lens profiles. Sci Rep 12, 8654 (2022). https://doi.org/10.1038/s41598-022-12694-4
Zhong Y, Wang K, Yu, X. et al. Comparison of trifocal or hybrid multifocal-extended depth of focus intraocular lenses: a systematic review and meta-analysis. Sci Rep 11, 6699 (2021). https://doi.org/10.1038/s41598-021-86222-1
Koh S. Mechanisms of Visual Disturbance in Dry Eye. Cornea. 2016;35 Suppl 1:S83-S88. doi: 10.1097/ICO.0000000000000998.
Kim J, Kim MK, Ha Y, et al. Improved accuracy of intraocular lens power calculation by preoperative management of dry eye disease. BMC Ophthalmol. 2021 3;21(1):364. doi: 10.1186/s12886-021-02129-5.
Donthineni PR, Deshmukh R, Ramamurthy C, Sangwan VS, Mehta JS, Basu S. Management of cataract in dry eye disease: Preferred practice pattern guidelines. Indian J Ophthalmol. 2023;71(4):1364-1372. doi:10.4103/IJO.IJO_2807_22
Venkateswaran N, Luna RD, Gupta PK. Ocular surface optimization before cataract surgery. Saudi J Ophthalmol. 2022;36(2):142-148. doi: 10.4103/sjopt.sjopt_190_21.
Yang F, Yang L, Ning X, et al. Effect of dry eye on the reliability of keratometry for cataract surgery planning. J Fr Ophtalmol. 2024;47(2):103999. doi: 10.1016/j.jfo.2023.04.016.
Data on File, Johnson & Johnson Surgical Vision, Inc. 2015. DOF2015OTH0005. Additivity of pseudophakic optical performance losses due to IOL
Nixon DR. Pattern of posterior capsule opacification models 2 years postoperatively with 2 single-piece acrylic intraocular lenses. 2010.
Kahraman G, et al., Intraindividual comparison of capsule behavior of 2 acrylic hydrophobic IOLs during 5-year follow up. J Cataract Refract Surg 2017;43(2):228-233. REF2018CT4047.
REF2014OTH0002 150 Data on File – Sensar Not associated with Glistenings – Literature Analysis
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About Sondra Black, OD

Dr. Black is an experienced Optometrist with private practice and extensive refractive surgery/cataract surgery experience. She works full-time for Johnson & Johnson Vision as the Head of Professional Strategy Surgical Americas. She has Clinical Director experience involving patient care, pre and postoperative management, clinical trial experience, and managing optometric network.

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