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Press release content from PR Newswire. The AP news staff was not involved in its creation.

Johnson & Johnson Vision Brings TECNIS Synergy And TECNIS Synergy Toric II PC-IOLS To North America For Cataract Patients

June 23, 2021 GMT
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TECNIS Synergy Toric II IOLs are now available in the United States.
1 of 5
TECNIS Synergy Toric II IOLs are now available in the United States.

The next-generation presbyopia-correcting intraocular lens (PC-IOL) offers cataract patients the widest^ range of continuous^^ vision and best near vision among leading PC-IOLs^^^^ 1,2,3,4,5

Now available in the U.S. and Canada, TECNIS Synergy PC-IOLs offers cataract patients the opportunity to experience excellent outcomes, with 9 out of 10 patients surveyed reporting they didn’t wear glasses following treatment6 ^^^

Throughout Cataract Awareness Month in June, Johnson & Johnson Vision is providing education about the symptoms of cataracts and the many treatments options available

^vs Acrysof® IQ PanOptix® IOL, TECNIS Symfony™ IOL, TECNIS® Multifocal IOL (United States), vs. Acrysof® IQ PanOptix® IOL, AT Lisa Trifocal IOL and FineVision IOL (Canada). Based on comparison of DFU defocus curves and a head to head clinical study vs. Acrysof® IQ PanOptix® IOL.

^^Continuous 20/32 or better ^^^Based on interim 6-months post-operative data ^^^^vs. Acrysof® IQ PanOptix® IOL

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SANTA ANA, Calif., June 23, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced the availability of TECNIS Synergy and TECNIS Synergy Toric II IOLs in the United States and Canada. These next-generation PC-IOLs combine the best of extended depth of focus and multifocal technologies to deliver the widest^ range of continuous^^ vision and the best near vision among leading PC-IOLs, ^^^^ 4 without the visual gaps seen with some existing multifocal technologies. 1, 2, 3, 5 Ophthalmologists across North America are now able to use this breakthrough PC-IOL to help treat their cataract patients, offering them the opportunity to experience excellent outcomes.^ ^^^6

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8835951-johnson-and-johnson-vision-tecnis-synergy-pc-iols/

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Cataracts are the leading cause of preventable blindness worldwide, impacting more than 100 million eyes, with more than 90% of people developing cataracts by the age of 65.7,8 Most people will develop cataracts at some point in their life, and modern cataract surgery is a safe and effective treatment that has a success rate of nearly 98%.9 However, in the U.S., 22% of people with cataracts say that their lack of knowledge of the procedure is a barrier to them seeking treatment,10 with many not realizing that there are intraocular lenses (IOL) available that may give them freedom from glasses. Today’s 55 – 64-year-olds are also using digital devices at much higher rates, and there’s been a rapid increase in adoption of LED lighting, requiring an IOL that delivers high-quality vision, at all distances, in all lighting conditions.

“My cataract patients are getting younger, have more active lifestyles, and want to be able to see their smartphones in the day and their menus at dinner,” said Dr. Vance Thompson, Vance Thompson Vision in Sioux Falls, South Dakota.*** “They have high expectations for their vision following cataract surgery, and the patients I’ve implanted with TECNIS Synergy™ IOL have not been let down. This new lens has provided the wide range of continuous^^ vision patients are looking for, with great image contrast throughout the day, even in low lighting conditions.” ^^^^11

“I’ve been using the TECNIS Synergy IOL for the past year and have been extremely impressed with the wide range of continuous^^ vision it provides,” said Dr. Sheldon Herzig, Herzig Eye Institute in Toronto and Ottawa.*** “This lens has provided the best near^^^ 4 vision for my patients, and most of my patients have said they have not used their glasses following surgery.6 I implanted my first TECNIS Synergy Toric II last week, which also corrects my patients’ astigmatism to improve both distance and near vision.”

The TECNIS Synergy IOL is built on the legacy TECNIS platform and delivers excellent performance, image contrast, and patient outcomes:

  • Widest^ range of continuous^^ vision among leading PC-IOLs — 93% of patients achieved 20/25 or better binocular distance-corrected visual acuity. ^^^^1,2,3,4,5 ,[12]
  • Best near^^^ 4 vision — patients gained an additional line of visual acuity at near distances versus a leading PC-IOL. ^^^^ 4
  • Superior image contrast^^^^ — achieved two times better image contrast in low lighting conditions compared to IOLs of comparable range.†11,12
  • High satisfaction with nighttime activities — 97% of patients were able see steps or curbs, 96% were able to see a menu in a dimly lit restaurant, and 90% were able to see objects and read street signs.^^^
  • Reduced need for glasses — 9 out of 10 patients studied didn’t wear glasses after surgery.6

“Around the world, the excitement for TECNIS Synergy PC-IOLs has been incredible and we’re proud of the excellent outcomes this innovation has delivered for patients,” said Sandor Palfi, Commercial Vice President of the Americas, Surgical at Johnson & Johnson Vision.**** “We are delighted to bring the most advanced TECNIS IOL to North America with TECNIS Synergy. Surgeons across the U.S. and Canada now have access to an IOL that will meet the needs of today’s cataract patients, who don’t want their life or their vision to be limited by their IOL.” 6,11 ^^^

The TECNIS Synergy PC-IOL was first launched in Europe and Asia Pacific in 2019 and is now available in Latin America, Canada, and the United States. Ophthalmologists in North America can learn more about the TECNIS Synergy PC-IOL portfolio at the Annual Canadian Ophthalmological Society virtual meeting later this week, and at the American Society of Cataract & Refractive Surgeons Annual Meeting in Las Vegas in July.

In addition to bringing the full TECNIS Synergy PC-IOL portfolio to the market in North America this month, Johnson & Johnson Vision is providing education to patients and caregivers about the symptoms of cataracts and the treatments options. In honor of Cataract Awareness Month, Johnson & Johnson is sharing cataract patient stories and information from ophthalmologist through various media, digital, and social media channels. For more information, patients and their caregivers are encouraged to visit beyondcataracts.com and follow Johnson & Johnson Vision on @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

^vs Acrysof® IQ PanOptix® IOL, TECNIS Symfony™ IOL, TECNIS® Multifocal IOL (United States), vs. Acrysof® IQ PanOptix® IOL, AT Lisa Trifocal IOL and FineVision IOL (Canada). Based on comparison of DFU defocus curves and a head to head clinical study vs. Acrysof® IQ PanOptix® IOL.
^^Continuous 20/32 or better
^^^Based on interim 6-months post-operative data
^^^^vs. Acrysof® IQ PanOptix® IOL
† Compared to IOLs of comparable range, i.e. trifocal IOLs (Acrysof® IQ PanOptix®, FineVision IOL, AT Lisa Trifocal IOL)

About The TECNIS® Family of IOLs
At Johnson & Johnson Vision, quality begins with the platform. The TECNIS® platform uses a proprietary combination of materials and design to deliver more for patients – more clarity with lower reflectance/lower dispersion vs competitor platform,13,14,15‡ the lowest level of chromatic aberration available on the market16‡‡, and almost complete elimination of spherical aberration17. The TECNIS® portfolio also delivers more image contrast - day and night - than the leading competitor platform14,18 ‡‡‡ and more stability to stand the test of time.19,20,21 ‡‡‡‡ Finally, TECNIS® delivers more choice for surgeons and patients - offering the broadest portfolio of IOLs, with solutions for every vision need, across a variety of different visual conditions and lifestyles.22

About Johnson & Johnson Vision
At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies**, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

About Johnson & Johnson Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision, and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding TECNIS Synergy™ and TECNIS Synergy™ Toric II IOLs. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Vision and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Johnson & Johnson Vision nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

‡Competitor platforms included are Hoya, Alcon & B&L Acrylic
‡‡Against IOLs that use Hoya, Alcon Acrylic, and B&L Silicone
‡‡‡Against Acrysof® IOL & Clareon IOL
‡‡‡‡Against Acrysof® IOL

INDICATIONS and IMPORTANT SAFETY INFORMATION FOR TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System, Model DFR00V and TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System, Models DFW150, DFW225, DFW300, DFW375, in the United States

INDICATIONS
The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ 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 Synergy™ 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 Synergy™ 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.

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. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starburst 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. The physician should carefully weigh the potential risks and benefits for each patient. 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 TECNIS Synergy™ Toric II IOL 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. 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. 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.

PRECAUTIONS
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. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. The TECNIS Synergy™ IOLs 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 TECNIS Synergy™ Toric II IOL. All preoperative surgical parameters are important when choosing a TECNIS Synergy™ Toric II IOL 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 Synergy™ 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 Synergy™ and TECNIS Synergy™ 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 predicted postoperative astigmatism.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS and IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY™ TORIC II OPTIBLUE IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELs DFW100, DFW150, DFW225, DFW300 AND DFW375

INDICATIONS FOR USE: The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ Toric II OptiBlue™ IOLs which are indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with or without presbyopia, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing vision far through near, a reduction of residual refractive cylinder and reduced spectacle dependence across a range of distances.

PRECAUTIONS: 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. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. 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. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. The intraocular pressure of implanted patients with glaucoma should be carefully monitored for postoperative changes.

WARNINGS: Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZFW implantation. The patients should be informed of the possibility of visual effects (such as halo or glare) in nighttime or poor visibility conditions. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZFW implantation since they may not fully benefit in terms of potential spectacle independence. Patients may perceive these visual effects as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. The lens model ZFW may affect image quality and lead to some reduction of contrast sensitivity compared to a monofocal lens. Therefore, patients should exercise caution when driving at night or in poor visibility conditions.

Rotation of toric lens model ZFW 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. Carefully remove all viscoelastic from the capsular bag. Residual viscoelastic may allow the lens to rotate, causing misalignment of the toric lens model ZFW with the intended axis of placement.

ADVERSE EVENTS: Potential adverse events during or following cataract surgery with implantation of the IOL may include but are not limited to: Endophthalmitis/intraocular infection, IOL dislocation, Persistent cystoid macular edema, Persistent corneal stromal edema, Persistent raised intraocular pressure (IOP) requiring treatment, Secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure). Adverse events can lead to permanent visual impairment and may require secondary surgical intervention, including intraocular lens exchange or explantation.

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

INDICATIONS and IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY™ OPTIBLUE® WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DFR00V, IN CANADA

INDICATIONS FOR USE: The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ OptiBlue® IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients with or without presbyopia, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing vision far through near and reduced spectacle dependence across a range of distances. The lens is intended to be placed in the capsular bag.

PRECAUTIONS: 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. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. 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. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. The intraocular pressure of implanted patients with glaucoma should be carefully monitored for postoperative changes.

WARNINGS: Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. The lens model ZFR00V should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZFR00V implantation. The patients should be informed of the possibility of visual effects (such as halo or glare) in nighttime or poor visibility conditions. Patients may perceive these visual effects as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZFR00V implantation since they may not fully benefit in terms of potential spectacle independence. The lens model ZFR00V may affect image quality and lead to some reduction of contrast sensitivity compared to a monofocal lens. Therefore, patients should exercise caution when driving at night or in poor visibility conditions.

ADVERSE EVENTS: Potential adverse events during or following cataract surgery with implantation of the IOL may include but are not limited to: Endophthalmitis/intraocular infection, IOL dislocation, Persistent cystoid macular edema, Persistent corneal stromal edema, Persistent raised intraocular pressure (IOP) requiring treatment, Secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure). Adverse events can lead to permanent visual impairment and may require secondary surgical intervention, including intraocular lens exchange or explantation.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

***Dr. Vance Thompson and Dr. Sheldon Herzig are paid consultants to Johnson & Johnson Vision.

****Sandor Palfi is an employee of Johnson & Johnson Vision, Inc., serving as Commercial Vice President of the Americas, with oversight for Surgical Vision in the U.S., Latin America and Canada regions.

© Johnson & Johnson Vision, 2021. All rights reserved.

1

DOF2019OTH4005 – Perez G. Simulated VA of the TECNIS SynergyTM IOL and AT Lisa Tri IOL. 5 May 2019.

2

DOF2019OTH4006 – Perez G. Simulated VA of the TECNIS SynergyTM IOL and FineVision IOL. 5 May 2019

3

TECNIS® Multifocal 1-Piece IOL ZKB00 and ZLB00 DFU – US – Doc. #Z311328. Rev. A, 04/2018. REF2019CT4049; TECNIS® Multifocal 1-Piece IOL ZKB00 and ZLB00 DFU - CAN – Doc. #Z7311006. Rev. A, 04/2015. REF 2018 CT4348.

4

DOF2020CT4014 - Forte 1: A Comparative Clinical Evaluation of a New TECNIS® Presbyopia Correcting Intraocular Lens Against a PanOptix® Intraocular Lens- Defocus Curves and Visual Acuity Results

5

TECNIS Symfony™ Extended Range of Vision IOL DFU - US -Doc. #Z311215. Rev. 01, 12/2017 REF2020MLT4051, TECNIS SYMFONY® EXTENDED RANGE OF VISION IOL AND TECNIS SYMFONY® TORIC EXTENDED RANGE OF VISION IOL IOL DFU – CAN – Doc. #Z311359. Rev. D, 11/2017

6

DOF2020CT4015- ("Forte 1"): A Comparative Clinical Evaluation of a New TECNIS® Presbyopia Correcting Intraocular Lens Against a PanOptix® Intraocular Lens-SPECTACLE WEAR AND SATISFACTION RESULTS

7

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8

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9

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10

The survey was conducted online in August 2020 by TRUE Global Intelligence—the in-house research practice of FleishmanHillard—among more than 6,000 adults 18 years of age or older across the United States, Japan, China, Germany, Russia, and the United Kingdom.

11

DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy™ OptiBlue®, and other lens models. 27 Mar 2020

12

DOF2019OTH4003 – Clinical Investigation of the TECNIS® Next-Generation IOL Model ZFR00 (TECNIS Synergy™ IOL): 6-Month POC Data. 23 Apr 2019.

13

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14

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15

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16

Data on File, DOF2018CT4007, Johnson &amp; Johnson Surgical Vision, Inc. 2018

17

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18

Data on File, DOF2018OTH 4004 Johnson &amp; Johnson Surgical Vision, Inc. 2018. (Modular transfer function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast.)

19

Nagata M, Matsushima H, Mukai K, Terauchi W, Senoo T, Wada H, Yoshida S. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010 Dec;36(12):2056-60.

20

Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express.

21

Auffarth GU, et al. Analysis of optical purity and optical quality of a new extended range of vision IOL. Poster presented at: The 20th ESCRS Winter Meeting; February2016, Athens, Greece.

22

Freeman W. Market Scope - 2017 IOL report: a global market analysis for 2016 to 2022. P. 79, 137, 174. REF2018MLT4002

Media Contact:
Erin Wolf-Valich
Johnson & Johnson Vision
ewolfval@its.jnj.com
718.730.2192

Investor Contact:
Sarah Wood
swood15@its.jnj.com
732.524.2617

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SOURCE Johnson & Johnson Vision