May 3, 2023

Johnson & Johnson Vision Presents Data at the 2023 ASCRS Annual Meeting Demonstrating Outstanding Outcomes and High Patient Satisfaction Across its Broad Portfolio of Surgical Vision Solutions

Studies highlight strong outcomes achieved with the TECNIS family of IOLs, offering patients a broad range of vision in all lighting conditions.^1,2,3,4

Long-term data reinforces safety and efficacy of iDesign for laser vision correction.

IRVINE, Calif. – May 3^rd – Johnson & Johnson Vision,** a global leader in eye health and part of Johnson & Johnson MedTech***, will present and support 43 company-sponsored and investigator-led studies evaluating innovation, outcomes and satisfaction rates across its surgical portfolio at the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in San Diego, CA, May 5-8. A complete listing of abstracts and events can be found on the ASCRS website.

“At Johnson & Johnson Vision, we are reimagining the scale and impact we can make across a patient’s life to pave the way for a new future of eye health,” said Lori Tierney,*** President of Americas, Johnson & Johnson Vision. "We are looking forward to sharing outcomes data at ASCRS that highlight how we are building on our proud legacy of firsts and elevating the standard of care for patients by pushing the frontiers of science and technology.”

At the meeting, Johnson & Johnson Vision will also debut its new ELITA Femtosecond Laser, which represents a generational leap in corneal refractive technology. Surgeons will have an opportunity to learn first-hand how ELITA delivers surgeon confidence and accuracy, practice efficiency, and offers improved visual outcomes and recovery for patients^5,6,7,8

“Our team of innovators consistently deliver solutions that are at the forefront of technological development, enabling surgeons to provide their patients with exceptional visual outcomes,” said Rajesh Rajpal,**** MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs, Johnson & Johnson Vision. “This year at ASCRS we are proud to present our legacy and new state-of-the-art surgical systems and TECNIS portfolio of IOLs that reliably deliver the outstanding results surgeons and their patients are looking for in vision correction.”

Highlights of Data to be Presented at the Meeting

Studies Reinforce Excellent Outcomes with TECNIS Symfony OptiBlue, Offering Minimized Dysphotopsia Profile and Full Range of Vision

The TECNIS Symfony OptiBlue, a diffractive EDOF IOL, was designed to deliver superior contrast and low-light performance. Data being presented shows that the newest TECNIS PC-IOL provided significant improvements in patient-reported symptoms of halos and starbursts* and enabled a full range of vision when paired with the TECNIS Synergy, a hybrid multifocal EDOF IOL.

Paper Presentation: “Impact of Violet Light Filtration and High-Resolution Lathing on the Clinical Performance of a Diffractive Extended Depth of Focus IOL.” Chang D. Saturday, May 6, 2023, 8:00 AM – 8:05 AM, SDCC – Upper Level, Room 1B.
Paper Presentation: “Clinical and Patient-Reported Outcomes Following Implantation of a Pair of Two Different Violet-Filtering Presbyopia-Correcting IOLs.” Rocha K. Saturday, May 6, 2023, 8:05 AM – 8:10 AM, SDCC – Upper Level, Room 5A.

Data that Shows TECNIS Eyhance is Designed to Slightly Extend the Depth of Focus When Non-Dominant Eye is Targeted for Monovision

The TECNIS Eyhance IOL is a monofocal lens designed to slightly extend depth of focus. This new study reinforces that the lens delivers on this promise. Moreover, when non-dominant eyes were targeted for mini monovision, versus emmetropia for both eyes, patients achieved a better range of vision with no increases in visual disturbances.

Paper Presentation: “Defocus Curve, Spectacle Independence, Satisfaction & Visual Disturbances Using a Monofocal Plus IOL: Bilateral Emmetropia Vs Monovision.” Solomon K. Saturday, May 6, 2023, 1:40 PM – 1:45 PM, SDCC – Upper Level, Room 4.

Long-Term Data that Reinforce the Safety and Efficacy of iDESIGN 2.0

The iDESIGN Refractive Studio is the first and only topo-integrated, wavefront-guided technology, offering personalized laser vision correction. Long-term outcomes data being presented underscore that the system delivers high levels of visual acuity gain and patient- reported satisfaction, with a low incidence of complications that is in line with other treatment formats.

Paper Presentation: “Long-Term Outcomes for Laser Vision Correction Utilizing a New Topography-Integrated Wavefront Guided Aberrometer.” Coleman S. Saturday, May 6, 2023, 3:30 PM – 3:35 PM, SDCC – Upper Level, Room 5A.

All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services.

About Johnson & Johnson Vision*

At Johnson & Johnson Vision, part of Johnson & Johnson MedTech*, 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 MedTech^**

At Johnson & Johnson MedTechⁱ, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of ELITA. 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 Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; 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 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other 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. None of the Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Media Contacts

Maria Echeverria
Johnson & Johnson Vision
mechever@its.jnj.com
949-591-7530

Jamie Hall
PRECISIONeffect
Jamie.Hall@Precisionvh.com
724-417-0167

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 Rx Only 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 SYMFONY^™ OPTIBLUE^™ with TECNIS SIMPLICITY^® DELIVERY SYSTEM and TECNIS SYMFONY^™ TORIC II OPTIBLUE^™ EXTENDED RANGE OF VISION IOLS 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

Patients with any of the conditions described in the Directions for Use 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. Lenses should not be placed in the ciliary sulcus. The lens may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made for patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including a perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions may be significant enough that the patient may request removal of the IOL.

Rotation of the TECNIS Symfony^™ Toric II OptiBlue^™ IOLs away from their intended axis can reduce their astigmatic correction, and misalignment ˃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 implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes.

PRECAUTIONS

For the TECNIS Symfony^™ Toric II OptiBlue^™ IOL, variability in any preoperative surgical parameters (e.g., keratometric cylinder, incision location, estimated surgically induced astigmatism, or biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case, to avoid lens rotation.

This is a single use device, do not resterilize the lens or the delivery system. 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. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box.

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 for a complete listing of Indications and Important Safety Information.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance^TM and TECNIS^TM 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^TM 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^TM 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 should weigh the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Rotation of the TECNIS Eyhance™ 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.

PRECAUTIONS

The safety and effectiveness of the TECNIS Eyhance™ IOL has not been substantiated in clinical trials and the effects of the optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. This is a single use device, do not resterilize the lens or the delivery system. 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 (BSS) or viscoelastics is required when using the delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box.

ADVERSE EVENTS

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%.

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

INDICATIONS FOR USE FOR iDESIGN^® Refractive Studio

The STAR S4 IR^® Excimer Laser System and the iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN^® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre- operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Refractive Studio refraction as follows: Spherical equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less than or equal to 0.50 D, Cylinder Axis: If either the manifest cylinder, entered into the iDESIGN^® Refractive Studio, or the iDESIGN^® Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15° (0.5 D) to 7.5° (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre- operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR^® Excimer Laser System and iDESIGN^® Advanced WaveScan WaveFront^® System/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^®Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D; 18 years of age or older, and with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR^® Excimer Laser System and iDESIGN^®Advanced WaveScan Studio System/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with mixed astigmatism as measured by iDESIGN^® Advanced WaveScan Studio System /iDESIGN^® Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR^® Excimer Laser System and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with myopia as measured by iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D. Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System.The STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism from -6.00 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^®Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.50D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^®Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of hyperopia and hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^®Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ELITA FEMTOSECOND LASER

INTENDED USE/PURPOSE:

The ELITA™ System is an ophthalmic femtosecond laser intended to create a corneal flap in patients undergoing LASIK surgery or other surgery treatment requiring initial lamellar resection of the cornea. The ELITA™ System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. The ELITA™ Patient Interface is designed for exclusive use with the ELITA™ System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused. The ELITA™ System should only be operated by, or under the direct supervision of a trained physician with certification in laser safety and in the use of the ELITA™ System for corneal flaps.

INDICATIONS FOR USE:

The ELITA™ System is an ophthalmic femtosecond laser indicated in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA™ System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. The ELITA™ Patient Interface is designed for exclusive use with the ELITA™ System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused.

CONTRAINDICATIONS:

Lamellar resection for the creation of a corneal flap using the ELITA™ System is contraindicated if any of the following conditions exist. Contraindications include the following, but are not limited to: Corneal edema, Corneal lesions, Hypotony, Glaucoma, Keratoconus, Existing corneal implant, Corneal Dystrophy, Unstable Refractive error within the past year prior to treatment, Prior refractive surgery.

Undesirable Side Effects/Adverse Effects: Possible complications resulting from this surgery include the following. Potential complications are not limited to those included in this list.

Diffuse lamellar keratitis (DLK), Corneal edema, Corneal pain, Epithelial ingrowth, Epithelial defect, Infection, Corneal infiltrate/ulcer, Delayed healing, Corneal abrasion, Corneal erosion, Corneal haze, Corneal scar, Corneal scoring, Inhomogeneous stromal bed, Eye pain/excessive tearing/eye redness, Inflammation of the episclera, Iritis/Uveitis, Unexpected loss of corneal tissue, Corneal ectasia, Elevated IOP, Hemorrhage, Subconjunctival hemorrhage, Venous and arterial blockage, Retinal vascular accidents, Ocular penetration, Cataract formation, Dysphotopsia, Blurry vision or halo/starburst/glare around lights at night, Ghost/ double images, Foreign body sensation or dry eye, Ptosis, Anesthesia/drug reactions, Transient light sensitivity syndrome, Peripheral light spectrum/rainbow glare.

Vision Threatening Complications (these complications are uncommon, but possible following refractive surgery):

Perforation of the cornea, Retinal detachment, Partial or total loss of vision or eye. Intended Patient: Adults 22 years old or older with refractive error.

NOTE: Pregnant or nursing women were not included in the clinical trials conducted.

*Study compared dysphotopsia profile between the TECNIS Symfony™ IOL and the newer TECNIS Symfony™ OptiBlue™ IOL
**Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
***Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
****Rajesh Rajpal is an employee of Johnson & Johnson Vision, Inc., serving as Chief Medical Officer and Global Head of Clinical and Medical Affairs

1 Data on File. DOF2021CT4002. Johnson & Johnson Surgical Vision, Inc.: 2021
2 Data on File. DOF2020OTH4011. Johnson & Johnson Vision, Inc.: 2020
3 Data on File. DOF2015CT0020. Johnson & Johnson Vision, Inc.: 2015
4 DFU, TECNIS SYMFONYTM OPTIBLUE™ IOL. Z311558E, RevA.
5 ASCRS 2022 LASIK Flap Accuracy Comparison Between A New Femtosecond Laser and iFS®, Mahipal Sachdev
6 DOF2023OTH4002: The ELITA™ Femtosecond Platform Patient Interface Design
7 DOF2023RF4002: The ELITA™ Femtosecond Laser device description
8 0155-1910 ELITA operator's manual (Flap) US edition (v0.2) REF2023RF4014

PP2023MLT5343