Johnson & Johnson Vision Highlights New Data on Personalized Vision Approach with TECNIS Family of IOLs for Cataract Patients and Highlights Progress of Innovative Pipeline at the 2019 ASCRS•ASOA Annual Meeting

• New data shows personalized lens selection pairing the TECNIS Symfony IOL and TECNIS Multifocal IOL resulted in greater visual acuity across near, intermediate, distance and better improved patient satisfaction than bilateral implantation
• The potential clinical performance of TECNIS Synergy^ǂ, an investigational, next-generation presbyopia-correcting IOL for patients with cataracts, is demonstrated across visual acuities, contrast, and defocus curve
• New data show the acute and long-term efficacy of thermal pulsation technology for treatment of meibomian gland dysfunction using LIPIFLOW
• Research shows wavefront-guided technology used in the IDESIGN Refractive Studio improved pre-LASIK anatomical measurements

Santa Ana, Calif. May 1, 2019 – Johnson & Johnson Vision today announced that a series of new data will be presented that further support advancements and innovations in the treatment of cataracts, dry eye, and laser vision correction. These analyses will be presented at the 2019 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in San Diego, May 3-7, 2019.

“At ASCRS, Johnson & Johnson Vision will present new research and education that demonstrate how we are continuing to support eye care professionals in elevating the standard of care for patients across a lifetime of eye health needs,” said Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision. “Data will show how a personalized vision approach using the TECNIS Family of IOLs may deliver optimal outcomes for cataract patients, and show the potential clinical performance of our investigational, next-generation presbyopia correcting IOL, TECNIS Synergy^ǂ IOL.”

Johnson & Johnson Vision will also feature a new booth at ASCRS as well as a variety of interactive educational experiences for professionals including the TECNIS Experience, the LipiFlow Patient Experience Suite, the J&J Vision Learning Hub, and more.

Additionally, Johnson & Johnson Vision is proud to sponsor the 7th Annual ASCRS Foundation Run for Sight as part of the company’s ongoing commitment to connect patients with access to care. To help support this cause, register at: https://www.tracs.net/ascrs5k/registration.html.

A complete listing of abstracts related to Johnson & Johnson Vision can be found on the ASCRS website. Notable abstracts of interest are listed below.

Personalized Vision Approach with TECNIS Symfony IOL and TECNIS Multifocal IOL/p>

Data show that a personalized vision approach using a TECNIS Symfony IOL and TECNIS Multifocal IOL may provide patients improved near visual acuities without compromising distance, as well as deliver lower incidence of visual symptoms, and improve patient satisfaction.

^†“Visual Acuity Outcomes Post-Implantation of an Extended-Depth-of-Focus Intraocular Lens When Combined with a Multifocal +3.25D Add Intraocular Lens.” Solomon K. Saturday, May 4, 2019, 1:36 PM - 1:41 PM, SDCC Upper Level, Room 7B

^†“Spectacle Independence, Patient Satisfaction, and Visual Disturbances after Implantation of an Extended-Depth-of-Focus IOL Combined with a Multifocal +3.25D Add IOL.” Sandoval H. Saturday, May 4, 2019 2:15 PM - 2:19 PM, SDCC Upper Level, Room 7B

^†“Analysis of Patient Satisfaction, Visual, and Functional Outcomes after Bilateral Versus Paired Extended Range of Vision/+325 Multifocal IOL Implantation.” Kontos M. Sunday May 5, 2019 4:29 PM – 4:34 PM, SDCC Upper Level, Room 7B

^†“A Comparison Using Multiple Regression Analysis of Predictors of Patient Satisfaction with an EDOF/+3.25 Versus Bilateral +3.25 Versus Bilateral +4.00 Diffractive Multifocal IOLs at the Time of Cataract Surgery." Bucci F. Tuesday, May 7, 2019 8:50 AM - 8:55 AM, SDCC Upper Level, Room 7A

^†“IOL and +3.25D multifocal IOL mix and match implantation versus +2.75D multifocal IOL and +4.00D multifocal IOL.” Tchah HW. Tuesday, May 7, 2019 8:45 AM - 8:50 AM, SDCC Upper Level, Room 7A
 

EDUCATIONAL COURSE: ^†“Custom Cataract Surgery: Matching Lens-Based Presbyopia Correction for Personalized Vision,” Donaldson K, Kontos M, Educational Course. Saturday, May 4, 2019 3:00 PM- 4:30PM, SDCC Upper Level, Room 8

TECNIS Synergy^ǂ IOL, an Investigational, Next-Generation Presbyopia-Correcting IOL

By combining extended depth of focus and multifocal technologies, TECNIS Synergy^ǂ IOL is designed to deliver continuous high-contrast vision from intermediate through near¹, without compromising distance². Data to be presented at ASCRS demonstrated the lens’ performance across visual acuities, contrast, and defocus curves³. TECNIS Synergy^ǂ IOL will be commercially available later this year in Europe and is not yet approved in other markets.

“Initial Clinical Evaluation of a Next-Generation Intraocular Lens for Presbyopia Correction, and Spectacle Independence.” Chang D. H. Saturday, May 4, 2019 1:02 PM – 1:07 PM, SDCC Upper Level, Room 7B

LIPIFLOW Vectored Thermal Pulsation for Meibomian Gland Dysfunction

In one study, meibomian gland dysfunction (MGD) affected up to 86% of patients with dry eye disease.⁴ Effectively managing MGD before surgery has been shown to stabilize the tearfilm for accurate refractive measurements and reduce dry eye symptoms post-surgery^5-7. New data continue to support the safety and efficacy of the LIPIFLOW treatment, and may also increase, relative to untreated controls, the amount of visible meibomian gland structure assessed approximately one year after a LIPIFLOW treatment for MGD.

^†“Visible Meibomian Gland Structure Increases after Vectored Thermal Pulsation Treatment in Dry-Eye Patients with Meibomian Gland Dysfunction.” Epitropolous A. Monday, May 6, 2019 8:17 AM - 8:22 AM, SDCC Upper Level, Room 7A
 

^†“Effect of Thermal Pulsation System Treatment on Keratometry Measurements Prior to Cataract Surgery.” Matossian C. Monday, May 6, 2019 8:40 AM - 8:45 AM, SDCC Upper Level, Room 7A
 

^†“A Study of Clinical and Molecular Nociceptive Biomarkers in Patients Having Refractive Surgery and their Relationship with Thermal Pulsation Treatment.” Vaishnav V, Shetty R
Monday May 6, 2019, 1:48 PM - 1:53 PM, SDCC Upper Level, Room 1B

IDESIGN Refractive Studio for Wavefront-Guided Refractive Surgery

IDESIGN Refractive Studio is the only system to use topography-integrated, wavefront-guided technology⁸, enabling data-driven personalization. Data shows that the majority of patients see 20/16 or better six months after wavefront-guided, data-driven personalization prior to laser vision correction.

^†“Small-Incision Lenticule Extraction Versus Wavefront-Guided LASIK: Preliminary Results of a Prospective Study.” Manche E. Saturday, May 4, 2019 2:02 PM - 2:07 PM, SDCC Upper Level, Room 5B

^†“A Prospective Multicenter Post-Approval Study of Wavefront-Guided LASIK for Myopia Using a High-Definition Hartmann-Shack Aberrometer.” Maloney R; Kraff C; Coleman S. Monday, May 6, 2019 3:40 PM - 3:45 PM, SDCC Upper Level, Room 5A

“Patient-Reported Outcomes after Wavefront-Guided LASIK for Myopia Using a High-Definition Hartmann-Shack Aberrometer.” Kraff C; Coleman S; Maloney R. Tuesday, May 7, 2019 8:17 AM- 8:22 AM, SDCC Upper Level Room 5A

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

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 around the world. 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 and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

About Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world.  With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life.

*Comprising the surgery, orthopaedics, vision and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment

# # #

All trademarks are the intellectual property of Johnson & Johnson Surgical Vision, Inc.

© Johnson & Johnson Surgical Vision, Inc. 2019

LIPIFLOW is a trademark of TearScience. Inc.

Important Safety Information

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® FAMILY OF 1-PIECE IOLs

Rx Only

TECNIS^® MULTIFOCAL FAMILY OF 1-PIECE IOLs

INDICATIONS

The TECNIS^® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the conditions described in the Directions for Use should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions.

See Full Indications and Important Safety Information.

TECNIS Symfony^® AND TECNIS Symfony^® TORIC EXTENDED RANGE OF VISION IOLs

The TECNIS Symfony^® Extended Range of Vision IOL, Model ZXR00, 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 Model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symfony^® Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, 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 Model Series ZXT IOLs are intended for capsular bag placement only.

WARNINGS

Physicians considering lens implantation under any of the circumstances described in the Directions for Use should weigh the potential risk/benefit ratio as such patients 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.

See Full Indications and Important Safety Information.

ATTENTION

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

LIPIFLOW INDICATIONS FOR USE

The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including Meibomian Gland Dysfunction (MGD), also known as Evaporative Dry Eye or Lipid Deficiency Dry Eye.

CONTRAINDICATIONS

Do not use the LipiFlow System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.

• Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
• Ocular injury within prior 3 months
• Ocular herpes of eye or eyelid within prior 3 months
• Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
• Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
• Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)

PRECAUTIONS

The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the LipiFlow System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.

• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
• Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use
• Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren's syndrome)
• Taking medications known to cause dryness (e.g., isotretinoin (Accutane^®) and systemic antihistamines)
• Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)

In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

POTENTIAL ADVERSE EFFECTS

Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in

• Eyelid/eye pain requiring discontinuation of the treatment procedure
• Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion)
• Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)
• Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light)

Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include:

• Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens
• Physical pressure-induced injury to the eyelid
• Ocular surface (corneal) infection

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR^® LASER, THE iDESIGN^® REFRACTIVE STUDIO AND THE iDESIGN^® ADVANCED WAVESCAN STUDIO SYSTEM

Indications for Use

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 StudioSystem/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.

Conventional LASIK procedure using the STAR S4 IR^® Excimer Laser System

Laser assisted in situ keratomileusis (LASIK) procedure using the STAR S4 IR^® Excimer Laser System is intended for use: 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; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -14.0 D with or without refractive astigmatism from 0.5 to 5.0D*; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. In patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (£6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.

Conventional PRK procedure using the STAR S4 IR^® Excimer Laser System

Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR^® Excimer Laser System is intended for use: 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; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -6.0 D spherical equivalent at the corneal plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -12.0 D spherical myopia at the spectacle plane with no more than 4.0 D of refractive astigmatism1; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +1.0 and +6.0 D sphere at the spectacle plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.

Contraindications

Laser refractive surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane^®) for acne treatment or Amiodarone hydrochloride (Cordarone^®) for normalizing heart rhythm.

Warnings

LASIK is not recommended in patients who have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency rub their eyes often; have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect); are taking the medication Isotretinoin (Accutane);are taking antimetabolites for any medical conditions.

Precautions:

To reduce the risk of corneal ectasia, the posterior 250 microns (µm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions

Adverse Events:

Prior clinical study of monovision LASIK using the WaveScan Wavefront^® System aberrometer, supports the safety and effectiveness of iDESIGN^® driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Monovision in Presbyopic Patients with Low to Moderate Myopia and Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

LASIK label
Rx Only

1 Caution must be used to calculate treatment in MINUS CYLINDER at the spectacle plane (vertex distance 12.5 mm) before entering the refraction into the laser in order to conform with the Indications for Use.

 

 

References

¹Data on File, Johnson & Johnson Surgical Vision, Inc. 2019. DOF2019OTH4002.

²TECNIS Synergy IOL DFU, Model ZFR00V. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.

³“Initial Clinical Evaluation of a Next-Generation Intraocular Lens for Presbyopia

Correction, and Spectacle Independence.” Chang D. H. Saturday, May 4, 2019 1:02 PM

– 1:07 PM, SDCC Upper Level, Room 7B (Data to be presented at ASCRS)

⁴Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012; 31(5): 472-478.)

⁵Data on File 2018 (NCT01808560). Pilot study for treatment of Meibomian Gland Dysfunction (MGD) Prior to Cataract Surgery. Accessed from https://clinicaltrials.giv/show/NCT1808560.

⁶Jung JW, Han SJ, Nam SM, Kim TI, Kim EK, Seo KY. Meibomian gland dysfunction and tear cytokines after cataract surgery according to preoperative meibomian gland status. Clin Exp Ophthalmol. 2016;44(7):555-562. 

⁷Epitropoulos AT, Matossian C, Berdy GJ, et al. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. Journal Cataract Refract Surg. 2015 Aug;41(8):1672-7.

⁸iDESIGN Refractive Studio treatment calculations are made using wavefront measurements, and use either measured topography or keratometry for propagating the wavefront and compensating for the cosine effect (peripheral loss of laser energy due to corneal curvature)

^ǂ TECNIS Synergy is not available for sale or commercial use in any market.

^†Abstracts generated from Investigator Initiated Studies. Content is not owned or directed by Johnson & Johnson Vision. Please consult Johnson & Johnson Vision Medical Affairs team for information on approved indication, labelling, contraindications, and warnings.

For further information, contact:

Allie Holmes
Johnson & Johnson Vision
949-244-7012 (mobile)

AHolmes1@its.jnj.com

Jamie Hall

Pascale Communications, LLC

724-417-0167 (mobile)
jamie@pascalecommunications.com

 

 

^PP2019CT4478