The TECNIS PC-IOL Portfolio Powered by InteliLight delivers the best* contrast and low-light performance across the PC-IOL category1,2,3
TECNIS Symfony OptiBlue is now available in the U.S. and select countries in EMEA
IRVINE, Calif., Sept. 28, 2022 /PRNewswire/ -- Johnson & Johnson Vision,** a global leader in eye health and part of Johnson & Johnson MedTech,*** today announced availability of our presbyopia-correcting intraocular lens (PC-IOL) powered by InteliLight technology https://www.jnjvisionpro.com/intelilight, TECNIS Symfony OptiBlue IOL. This extended depth-of-focus (EDOF) lens expands presbyopia correction to more patients and joins TECNIS Synergy IOL, a high-performance hybrid lens designed for spectacle independence****, in the InteliLight portfolio. These two complementary products deliver superior* contrast and low-light performance across the PC-IOL category.1,2,3 The InteliLight portfolio will be on display at the 2022 American Academy of Ophthalmology's Annual Meeting (AAO) in Chicago, Sept. 30-Oct. 3.
Cataracts are the leading cause of preventable blindness worldwide, impacting more than 100 million eyes globally.4,5 Cataracts are a clouding of the lens in the eye, caused by a buildup of the eye's natural protein which changes the way the eye focuses light, therefore changing the color and clarity of vision.6 Most people will develop cataracts at some point in their life, however cataracts can be treated with surgery; modern cataract surgery is a safe and effective treatment that has a success rate of nearly 98%.7
"My goal as an eye care professional is to deliver the best outcomes for my patients, and to help them get back to some of the activities many of us take for granted — driving at night, going up and down the stairs in their homes in dim light, or just going out at night and enjoying dinner at a restaurant, all with less risk8," said Karolinne Rocha,****** MD, PhD, MUSC/Storm Eye Institute, Charleston, South Carolina "In my practice we've seen TECNIS Symfony OptiBlue IOL deliver good image contrast in the day and night, at all distances. Best of all, it has a minimized dysphotopsia profile that gives me the comfort I need to recommend presbyopia correction to more patients"
TECNIS Symfony OptiBlue IOL is powered by InteliLight, an innovative combination of three Johnson & Johnson Vision proprietary technologies: violet-light filter, echelette design and achromatic technology. The technology was first introduced in the TECNIS Synergy IOL.
"We know our patients' lives don't stop at sunset, and neither should their confidence in being able to see clearly or drive at night," said Nikki Sidi,******* Vice President, Global Strategic Marketing, Surgical Vision, Johnson & Johnson Vision. "The InteliLight PCIOL portfolio delivers best-in-category* contrast and low-light performance.1,2,3 And with TECNIS Synergy for spectacle independence and TECNIS Symfony OptiBlue for functional vision at every distance, surgeons can now choose the best in low-light performing PCIOLs, according to their patients' needs."
The TECNIS PC-IOL portfolio powered by InteliLight is now available for ophthalmologists to use in the U.S. and select countries in EMEA. The lenses in the portfolio, TECNIS Synergy IOL and TECNIS Symfony OptiBlue IOL, are also available in Toric II for excellent rotational stability15 for patients with astigmatism. To learn more about the InteliLight portfolio, please visit https://www.jnjvisionpro.com/intelilight in the U.S.
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 MedTech, 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 TECNIS Symfony OptiBlue IOL. 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, any of the other Johnson & Johnson MedTech Companies 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 2, 2022, 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. Neither Johnson & Johnson Vision, the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*TECNIS Symfony™ OptiBlue™ vs AcrySof® ReSTOR® +2.5 D and AcrySof® IQ Vivity®. TECNIS Synergy™ vs PanOptix® 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, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.
**** Individual results will vary. Some TECNIS Synergy™ patients may require spectacles post-surgery.
*****Compared to lenses without lathing process.
****** Karolinne Rocha, MD, PhD is a consultant for Johnson & Johnson Vision.
*******Nikki Sidi is an employee of Johnson & Johnson Vision, Inc., serving as Vice President of Global Strategic Marketing for Surgical Vision.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY™ OPTIBLUE™ and TECNIS SYMFONY™ TORIC II OPTIBLUE™ EXTENDED RANGE OF VISION IOLs with TECNIS SIMIPLICITY® 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
Interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is recommended. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the optical design. Target emmetropia for optimum visual performance. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.
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 SYNERGY™ and TECNIS SYNERGY™ TORIC II IOLs
The TECNIS Synergy™ IOL, Model ZFR00V, 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. Compared to an aspheric monofocal lens, the TECNIS Synergy™ IOL mitigates 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. The TECNIS Synergy™ Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, are indicated for primary implantation for the visual correction of aphakia and for the 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™ Toric II 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.
© Johnson & Johnson Surgical Vision, Inc. 2022. All rights reserved.
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
1 Data on file. DOF2020OTH4010 Johnson & Johnson Vision, Inc. Santa Ana, Calif.
2 Data on file. DOF2015CT0020 Johnson & Johnson Vision, Inc. Santa Ana, Calif.
3 DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy™ OptiBlue®, and other lens models. 27 Mar 2020.
4 World Health Organization - Priority Eye Diseases. REF 2016 OTH 0004.
5 World Health Organization. Blindness and Impairment. https://www.who.int/en/news-room/fact-sheets/detail/blindness-and-visual-impairment.
6 American Optometric Association. Cataract. https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/cataract?sso=y. Accessed May 24, 2022.
7 Vision Health Initiative, Common Eye Disorders. Centers for Disease Control and Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html
8 Szanton SL, Walker RK, Roberts L, Thorpe RJ, Jr., Wolff J et al. 2015. Older adults' favorite activities are resoundingly active: findings from the NHATS study. Geriatr Nurs 36 (2): 131-135.
9 ARVO 2020_Effect of blocking violet light in extended depth of focus IOL: SC2019CT4056.
10 Mainster MA. Blue-blocking Intraocular Lenses: Myth or Reality? Am J Ophthalmol. 2009;1:8-10. REF2014CT0140 Blocks shortest wavelengths (p.1).
11 ARVO 2019_Optical and Visual performance of violet blocking IOL: SC2019CT4025
12 Effect of blocking violet light in EDOF IOLs. JNJ ArvoAbstractMay 2020/Optical and visual performance of violet blocking IOL SC2019CT4025.
13 DOF2020CT4011: DOF Effect of blocking violet light on light scatter in Tecnis Symfony™ IOLs (v1.0).
14 InteliLight US Sales Aid. PP2022MLT5751
15 DOF2021CT4019 - Clinical investigation of rotational stability of the TECNIS™ Toric II IOL- Steele Study NXGT-202-QROS. 20 Aug. 2021.
SOURCE Johnson & Johnson Vision
