Johnson & Johnson Vision Launches TECNIS Synergy and TECNIS Eyhance Intraocular Lenses (IOLs) for the Treatment of Cataracts in Canada

• TECNIS Synergy IOL, a breakthrough presbyopia-correcting IOL (PC-IOL), delivers continuous high-contrast vision for patients with cataracts from far through near, day and night^1,2 
• TECNIS Eyhance, a revolutionary IOL that provides high-quality vision at both intermediate and far distances³ 

Toronto, Ontario, Canada, August 13, 2020 – Johnson & Johnson Vision, *a global leader in eye health, today announced Health Canada approval and July availability of its TECNIS Synergy and TECNIS Eyhance IOLs to the Canadian market. Cataracts are the leading cause of blindness globally⁴, with more than 90 percent of people developing cataracts by age 65.⁵

The TECNIS Synergy, originally launched in Europe in September 2019, is a breakthrough solution that delivers continuous high-contrast vision from far through near,¹ allowing patients to see at their ideal distances, and provide superior low-light contrast benefits from day to night.^††2 The TECNIS Eyhance, originally launched in Europe in February 2019, is a next-generation intraocular lens that goes beyond the expectations of the monofocal category to allow patients to experience high-quality vision at both intermediate and far distances.³

TECNIS Synergy, New Presbyopia-Correcting IOL that Combines Multifocal and EDOF Technologies

To create the TECNIS Synergy IOL, the Johnson & Johnson Vision R&D team disrupted the traditional IOL development approach – designing the optimal defocus curve for clinical performance¹, then developing the technology to deliver for it. The result – a revolutionary presbyopia-correcting lens that:

• Gives broad range of continuous vision6 covering from distance to 33 cm^{†† 7,8,9}
• Eliminates the visual gaps present in trifocal and other multifocal technology, offering patients the freedom to focus within the range^{†† 7,8,9}
• Continues to deliver superior contrast regardless of light conditions^{†† 2}
• Violet filtering is shown to reduce halo intensity for tasks like night driving,10 as demonstrated in clinical simulations. TECNIS Synergy has an acceptable halo profile.¹

TECNIS Eyhance, an IOL that Defies Monofocal Category Convention

Today most lenses in the monofocal category only correct vision to help patients with cataracts see things at a distance, and thus do not improve the intermediate vision that is required for many important daily tasks. TECNIS Eyhance IOL is a next-generation IOL that elevates expectations established by the monofocal category by providing enhanced intermediate vision.^{3, 11} TECNIS Eyhance IOL defies monofocal convention of 20/20 to:¹¹

• Deliver significantly improved intermediate vision, along with 20/20 distance vision^3,11
• Offer a breakthrough refractive design that is progressive in power
• Feature a low incidence of halo, glare or starbursts (i.e., bright circles of light that surround headlights and other light sources).¹¹

This lens enables most patients to perform certain activities requiring intermediate vision with greater ease, and to engage in activities of personal interest, including favourite hobbies such as cooking, reading a mobile device or reading a book.¹¹

“These new TECNIS lenses are a very promising step forward in the pursuit of more natural vision for our cataract and refractive patients! The ability to provide a more continuous range of vision from near to intermediate and far with the (TECNIS) Synergy IOL, and provide high monofocal-like safety with improved intermediate vision with the (TECNIS) Eyhance IOL allows us more choices for our patients,” explained Dr. Ike Ahmed,** Assistant Professor and Director of the Glaucoma and Advanced Anterior Surgical Fellowship, University of Toronto, Canada.

“We’re excited to offer two IOLs to support eye care providers as they return to practice – each meeting a specific unmet need for the cataract patient community,” said Rajesh K. Rajpal***, MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs at Johnson & Johnson Vision. “TECNIS Synergy IOL is a PC-IOL that delivers continuous high-contrast vision from far through near, day and night, and TECNIS Eyhance defies monofocal conventions to offer intermediate vision, along with the expected distance. Both are built on the strong foundation of the TECNIS Family of IOLs, known for the quality of their optics and outcomes.”

About Cataracts and Presbyopia 

Left untreated, cataracts cause vision to deteriorate over time. Cataract surgery is the most common surgery performed around the world.¹² Many people who have cataracts experience other problems with their vision, such as presbyopia. Cataract surgery is a unique opportunity to address presbyopia without an additional procedure. Presbyopia is a progressive eye condition, which makes it difficult to focus on close objects and usually becomes noticeable around 40 years of age.¹² 

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 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****

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. 

About TECNIS Eyhance IOL 

TECNIS Eyhance IOL is a next-generation IOL that elevates expectations for the monofocal category by providing enhanced intermediate vision.¹¹ Where monofocal lenses only correct vision to help patients with cataracts see things at a distance, and do not improve the intermediate vision that is required for many important daily tasks, TECNIS Eyhance delivers distance and enhanced intermediate vision.¹¹

About TECNIS Synergy IOL 

TECNIS Synergy IOL creates a new standard in presbyopia-correcting intraocular lens (PC-IOL) technology, allowing patients to experience continuous high-contrast vision from far through near, even in low-light conditions.^1,2,7 The Johnson & Johnson Vision R&D team changed their approach to IOL development – designing the optimal defocus curve for clinical performance, then developing the technology to deliver for it. The result – a revolutionary lens with optics that outperforms existing PC-IOLs on the market.^††† 

General Adverse Events for IOLs: 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 intraocular surgical intervention (including implant repositioning, removal, AC tap performed later then one week after cataract surgery, 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. 

ATTENTION: Reference the Directions for Use for Important Safety Information. 

CAUTION: Federal law restricts this device to sale and use by or on the order of a physician. 

†† Non head-to-head bench study. Tested with PanOptixIOL, AT Lisa Trifocal IOL and FineVisionIOL 

††† Based on non head-to-head bench study. 

* Johnson & Johnson Vision represents the products and services of Johnson & Johnson Vision Care, division of Johnson & Johnson Inc. and AMO Canada Company. 

** Dr. Ike Ahmed is a paid consultant to Johnson & Johnson Vision. 

*** Dr. Rajesh K. Rajpal is an employee of Johnson & Johnson Surgical Vision, Inc., serving as Head of Clinical and Medical Affairs across both the Surgical Vision and Vision Care organizations. 

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

© 2020 AMO Canada Company 

Media Contacts:

Jamie Hall
Pascale Communications
jamie@pascalecommunications.com
724-417-0167

Leanne Kahn
Johnson & Johnson Vision
LKahn1@its.jnj.com
857-205-8415

 

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

2 DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy OptiBlue IOL, and other lens models. 27 Mar 2019. 

3 TECNIS Eyhance IOL — Product monograph EMEA 2019, table 4.1 SC2019CT4002. 

4 World Health Organization - Priority Eye Diseases. REF2016OTH0004. 

5 University of Michigan Kellogg Eye Center website. http://www.kellogg.umich.edu/patientcare/conditions/cataract.html. Accessed October 28, 2017. REF2016OTH0327. 

6 TECNIS Synergy IOL DfU– OUS – Doc. #Z311358. Rev. 02, 02/2019. REF2019OTH4259 

7 DOF2019OTH4004 –Perez G. Simulated VA of the TECNIS Synergy IOL and PanOptixIOL. 12 April 2019. 

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

9 DOF2019OTH4006 –Perez G. Simulated VA of the TECNIS Synergy IOL and FineVisionIOL. 5 May 2019. 

10 Canovas C. et al. Optical and Visual Performance of Violet Blocking Intraocular Lenses. ARVO Poster 2019. SC2019CT4025. 

11 DOF2018CT4015 – Clinical evaluation of the TECNIS Eyhance IOL Model ICB00, 6-month clinical study. Sep. 2018. 

12 American Optometric Association. Presbyopia. American Optometric Association (AOA) Web site: https://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/presbyopia. Accessed July 3, 2019. REF2019CT4316.  

TECNIS Synergy Important Safety Information 

Indications for Use: The Model ZFR00V 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. 

Precautions: 1. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended. 2. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design. 3. 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. 4. Do not resterilize or autoclave the lens. 5. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. 6. Do not store the lens in direct sunlight or at a temperature greater than 45oC (113oF). 7. Do not re-use the lens. 8. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. 9. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. 10. Care should be taken to achieve centration of the intraocular lens. 11. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. 12. When the insertion system is used improperly, the haptics of the IOL may become broken. 13. 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. 14. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. 15. A patient implanted with an intraocular lens should be monitored on a regular basis for long-term postoperative follow-up. 16. 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: 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) Recurrent severe anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye. b) Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat posterior segment diseases. c) 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). d) A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. e) Circumstance 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 potentially good vision in only one eye. 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. 2. The lens model ZFR00V should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. 3. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZRF00V 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. 4. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZRF00V implantation since they may not fully benefit in terms of potential spectacle independence. 5. The lens model ZRF00V 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 - General Adverse Events for IOLs: Potential adverse events during or following cataract surgery with implantation of the IOL may include but are not limited to: 1. Endophthalmitis/intraocular infection 2. Hypopyon 3. Hyphema 4. IOL dislocation 5. Persistent cystoid macular edema 6. Pupillary block 7. Retinal detachment/tear 8. Persistent corneal stromal edema 9. Persistent iritis 10. Persistent raised intraocular pressure (IOP) requiring treatment 11. 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 safety information. 

TECNIS Eyhance IOL Important Safety Information 

Indications For Use: The TECNIS Eyhance IOL, model ICB00, is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provide similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only. 

Precautions: 1. Autorefractors may not provide optimal postoperative refraction of patients with TECNIS Eyhance IOL, model ICB00, lenses. Manual refraction with maximum plus technique is strongly recommended. 2. Recent contact lens usage may affect the patient’s refraction; therefore, for patients that wear contact lenses, surgeons should establish corneal stability without contact lenses prior to determining IOL power. 3. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. 4. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. 5. Do not store the lens in direct sunlight or at a temperature greater than 113oF (45oC). Do not autoclave the intraocular lens. 6. Do not re-use the intraocular lens. 7. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. 8. The lens is designed for optimum visual performance when emmetropia is targeted. 9. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. 10. When the insertion system is used improperly, the haptics of the TECNIS Eyhance IOL, model ICB00, may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. 

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. 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. 2. The TECNIS Eyhance IOL, model ICB00, should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus. 3. Johnson & Johnson Surgical Vision, Inc. IOLs are labelled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. 

The resterilization/reprocessing of the IOLs 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. 

Adverse Events - General Adverse Events for IOLs: Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: 1. Endophthalmitis/intraocular infection 2. Hypopyon 3. Hyphema 4. IOL dislocation 5. Cystoid macular edema 6. Pupillary block 7. Retinal detachment/tear 8. Persistent corneal stromal edema 9. Persistent iritis 10. Persistent raised IOP (intraocular pressure) requiring treatment 11. Acute corneal decompensation 12. Secondary intraocular surgical intervention (including implant repositioning, removal, AC tap performed later then one week after cataract surgery, or other surgical procedure) 13. Any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. 

Attention: Reference the Directions For Use for a complete listing of indications and safety information.