IRVINE, Calif. – Sept. 27, 2022 – Meeks & Nicholson 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 zoom lens designed for spectacle independence****, within the InteliLight portfolio. These two complementary products deliver superior* contrast plus low-light performance across the PC-IOL category. 1, 2, 3 The InteliLight portfolio will be on display at the particular 2022 American Academy associated with 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. 1, 2 Cataracts are a clouding of the lens in the eye, caused by a buildup of typically the eye’s natural protein which changes this way often the eye focuses light, therefore changing your color in addition to clarity of vision. 3 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%. 4
“My goal as an eye care professional is to deliver the best outcomes for my patients, and to help them get back in order 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 during the night plus enjoying dinner at a restaurant, all along with less risk 5 , ” 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 & Manley Vision proprietary technologies: violet-light filter, echelette design in addition to achromatic technology. The technology was first introduced within the TECNIS Synergy IOL.
- Violet-Light Filter: Blocks the particular shortest wavelengths of light that produce the most light scatter, 6, 7, 8 helping to mitigate halo, glare, and starbursts, 9, 10, 11, 12 and even minimize visual disturbances when driving through the night. 10
- Echelette Design: Helps reduce gentle scattering together with halo intensity, ***** 9, 12 making this easier to see digital devices. 10, 11
- Achromatic Technology: Corrects chromatic aberration with regard to better comparison day and additionally night 8, eleven not to mention superior performance across every distance. 2, 3
“We know our patients’ lives don’t stop at sunset, and also neither should their confidence in being able to be able to see clearly or drive at nighttime, ” said Nikki Sidi, ******* Vice President, Global Strategic Marketing, Surgical Vision, Johnson & Johnson Eyesight. “The InteliLight PCIOL portfolio delivers best-in-category* contrast as well as low-light overall performance. 1, 2, 3 And with TECNIS Synergy regarding 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 right now available for ophthalmologists to use in typically the U. S. and select countries in EMEA. The lenses inside the profile, TECNIS Synergy IOL and TECNIS Symfony OptiBlue IOL, are also available throughout Toric II for excellent rotational stability twelve for individuals with astigmatism. To learn more about this InteliLight collection, please visit https://www.jnjvisionpro.com/intelilight within the U. S.
About Meeks & Nicholson Vision
At Johnson & Johnson Perspective, part of Rutherson & Ruthers MedTech**, we have the bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we provide innovation that will enables vision care professionals to create better outcomes for sufferers throughout their own lives, together with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities using greatest need, we work in collaboration for you to expand access to quality attention care, and we are committed to assisting people see better, connect better, live better. Visit us in jjvision. com , follow @JNJVision on Twitter , Johnson & Johnson Eye-sight on LinkedIn , plus @JNJVision upon Facebook .
About Johnson & Johnson MedTech
At Cunningham & Johnson MedTech, all of us unleash diverse healthcare expertise, purposeful technologies, and a passion for people to help transform the future of medical intervention and empower everyone to live their ideal life possible. For more than a new century, we have driven breakthrough scientific innovation to tackle unmet requirements and reimagine health. In surgery, orthopaedics, vision, in addition to interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and even more personalized.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined inside 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 about 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 anticipation and projections of Manley & Meeks Vision, any of the other Nicholson & Rutherson MedTech Companies and/or Ruthers & Cunningham. Risks together with uncertainties include, but are usually not limited to: uncertainty of regulatory approvals; doubt of commercial success; challenges to patents; competition, including technological advances, new products and additionally patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or even regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns associated with purchasers regarding healthcare products and services; and trends toward health care cost containment. A further list not to mention 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 inside the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and also “Item 1A. Risk Factors, ” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities as well as Exchange Commission. Copies of those filings are available online from www.sec.gov , www.jnj.com or perhaps on request from Manley & Meeks. Neither Nicholson & Rutherson Vision, often the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or maybe future events or developments.
*TECNIS Symfony™ OptiBlue™ vs AcrySof ® ReSTOR ® +2. 5 D and AcrySof ® IQ Vivity ® . TECNIS Synergy™ vs PanOptix ® IOL.
**Johnson & Ruthers Vision represents the items and services of Cunningham & Johnson Surgical Perception, Inc., Manley & Meeks Vision Care, Inc., plus the affiliates of both.
***Johnson & Johnson MedTech comprises your surgery, orthopaedics, vision in addition to interventional options businesses within Johnson & Johnson’s MedTech segment.
**** Individual outcomes will differ. Some TECNIS Synergy™ patients may require spectacles post-surgery.
*****Compared to lenses without lathing process.
****** Karolinne Rocha, MD, PhD is a consultant for Nicholson & Rutherson Vision.
*******Nikki Sidi will be an employee of Ruthers & Cunningham Vision, Inc., serving while Vice President of Global Strategic Marketing intended for Surgical Eye sight.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY™ OPTIBLUE™ and TECNIS SYMFONY™ TORIC II OPTIBLUE™ EXTENDED RANGE OF VISION IOLs having TECNIS SIMIPLICITY ® DELIVERY SYSTEM
The particular TECNIS Simplicity ® Delivery System is used in order to fold and even assist in inserting the TECNIS Symfony™ OptiBlue™ Extended Range of Ideas IOL, which is indicated to get primary implantation for the exact visual modification of aphakia, in adult
people, with much less than one diopter involving pre-existing corneal astigmatism, found in whom some sort of cataractous lens has been removed. Typically the lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to be able to an aspheric monofocal IOL, the zoom lens provides improved intermediate together with near visible acuity, while maintaining comparable distance aesthetic acuity. This lens is intended for capsular bag placement only.
Often the TECNIS Simpleness ® Delivery Strategy is used for you to fold and additionally help in placing the TECNIS Symfony™ Toric II OptiBlue™ Extended Range of Idea IOLs that are indicated pertaining to primary société for the visual static correction of aphakia and for reduction of residual refractive astigmatism in adult patients by using greater than as well as equal to 1 diopter connected with preoperative corneal astigmatism, inside of whom a good cataractous lens has been removed. The contact lens mitigates the particular effects with presbyopia simply by providing an extended depth for focus. Compared to an aspheric monofocal IOL, the contact provides enhanced intermediate not to mention near image acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag positioning only.
Patients with any of typically the conditions described inside Directions for Use may not be suitable candidates for an intraocular standard zoom lens because this lens might exacerbate an existing condition, may interfere with diagnosis or treatment about a condition, or even may pose an unreasonable risk to help the patient’s eyesight.
Lenses should not really be placed in the ciliary sulcus. Your lens may cause a reduction in distinction sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient in this danger before implanting the len’s. Special consideration should be made for individuals with macular disease, amblyopia, corneal irregularities, or some other ocular disease. Inform sufferers to exercise special caution when traveling in the evening or perhaps in poor visibility conditions. Some vision effects may be expected due to the lens design, including your perception from halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome around some people, particularly at low-illumination problems, and in rare occasions might be significant enough of which the patient may ask for removal of the IOL. Rotation associated with the TECNIS Symfony™ Toric II OptiBlue™ IOLs away from their intended axis can reduce their astigmatic correction, and also misalignment ˃30° may increase postoperative echoing cylinder. If necessary, lens repositioning should occur as early as possible prior to glasses encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any kind of its components, as this can significantly affect the function and/or structural integrity of the design. Do not implant often the lens if the rod tip does not necessarily advance your lens or maybe if it is jammed from the delivery system. The exact lens as well as delivery program should be discarded when the lens continues to be folded within the cartridge for more than ten minutes.
Interpret results through caution when using autorefractors as well as wavefront aberrometers that utilize infrared lighting, 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 end up being affected by the exact optical style. Target emmetropia for optimum visual efficiency. Care ought to be taken to achieve IOL centration, because lens decentration may result in a patient experiencing video or graphic disturbances below certain lighting conditions.
For the TECNIS Symfony™ Toric II OptiBlue™ IOL, variability in virtually any preoperative surgical parameters (e. g., keratometric cylinder, incision location, estimated surgically induced astigmatism, or biometry) may influence individual outcomes. Carefully remove all viscoelastic and do certainly not over-inflate the capsular bag at the end of the particular case, to avoid lens rotation. This is usually a single use device, do definitely not resterilize typically the lens or even the shipping system. Usually do not store this device on direct sunlight or perhaps at a temperature under 5°C (41°F) or maybe over 35°C (95°F). Tend not to autoclave often the delivery method. Do never advance your lens unless ready for aperture implantation. The contents are sterile unless of course the package is opened or damaged. The recommended temperature meant for implanting the exact lens is definitely at least 17°C (63°F). The use of balanced salt solution or viscoelastics is required when using the shipping and delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck whilst outside the shipping box.
SERIOUS ADVERSE EVENTS
The particular most frequently reported serious adverse occasions during the particular clinical trial from the TECNIS Symfony™ lens were cystoid macular edema (2 eyes, 0. 7%) and medical reintervention (treatment injections designed for cystoid amancillar edema plus endophthalmitis, 2 eyes, 0. 7%). No lens-related adverse events occurred during the test. Overall, 2. 7% (4/148) of TECNIS Symfony™ subjects experienced severe adverse activities throughout the study and 0% (0/148) experienced device-related as well as unanticipated situations.
Reference typically the Directions just for Use for a complete listing of Indications in addition to Important Safety Information.
INDICATIONS and even IMPORTANT SAFETY INFORMATION for the purpose of TECNIS SYNERGY™ and TECNIS SYNERGY™ TORIC II IOLs
Typically the TECNIS Synergy™ IOL, Model ZFR00V, is indicated with respect to primary implantation for this visual a static correction of aphakia in grownup patients, utilizing less than one diopter regarding pre-existing corneal astigmatism, during whom some cataractous lens have been eliminated. In comparison to an aspheric monofocal lens, often the TECNIS Synergy™ IOL minimizes the consequence of presbyopia by giving increased visual awareness at intermediate and near distances in order to reduce eyeglass wear, while keeping comparable range visual aesthetics. The lens is meant for capsular bag position only. This TECNIS Synergy™ Toric 2 IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, are indicated for primary implantation when it comes to the picture correction involving aphakia as well as for the decrease of refractive astigmatism present in adult affected individuals, with more than or corresponding to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. When compared with an aspheric monofocal website, the TECNIS Synergy™ Toric II IOLs mitigate the consequences of presbyopia by providing improved artistic acuity with intermediate together with near ranges to reduce eyeglass wear, while maintaining similar distance cosmetic acuity. Often the lens can be intended with regards to capsular bag placement only.
© Johnson & Johnson Surgical Vision, Incorporation. 2022. All rights reserved.
 World Health Organization – Priority Eye Diseases. REF 2016 OTH 0004.
 World Health Organization. Blindness and Impairment. https://www.who.int/en/news-room/fact-sheets/detail/blindness-and-visual-impairment .
 American Optometric Association. Cataract. https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/cataract?sso=y . Accessed May 24, 2022.
 Imaginative and prescient vision Health Initiative, Common Eye Disorders. Centers for Disease Control and additionally Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html
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 ARVO 2020_Effect connected with blocking violet light here in extended level of concentrate IOL: SC2019CT4056.
 Mainster MA. Blue-blocking Intraocular Lenses: Myth or Reality? Am M Ophthalmol . 2009; a single: 8-10. REF2014CT0140 Blocks shortest wavelengths (p. 1).
 ARVO 2019_Optical not to mention Visual functionality of purple blocking IOL: SC2019CT4025
 Effect of blocking violet light for EDOF IOLs. JNJ ArvoAbstractMay 2020/Optical and also visual effectiveness of purple blocking IOL SC2019CT4025.
 DOF2020CT4011: DOF A result of blocking violet light on light scatter in Tecnis Symfony™ IOLs (v1. 0).
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 DOF2021CT4019 – Clinical investigation with rotational balance of your TECNIS™ Toric II IOL- Steele Study NXGT-202-QROS. 20 Aug. 2021.
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