Johnson & Johnson Vision Receives FDA Clearance and CE Mark for Next-Generation Phacoemulsification Machine, VERITAS™ Vision System
VERITAS™ Vision System to introduce innovations in fluidics management and usability to fuel surgeons' performance in every cataract procedure, from the easiest to most challenging
SANTA ANA, Calif., April 21, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced the FDA 510(k) clearance and CE mark of its next-generation phacoemulsification innovation, the VERITAS™ Vision System1. The high-performance phacoemulsification system features technologies that allow surgeons to guide through any lens density with less surge and more stability. The new system also provides advancements in ergonomics to further enhance usability during cataract surgery.
More than 90% of people develop cataracts by the age of 65,2 and cataract surgery is one of the most common outpatient procedures performed today with a success rate of approximately 98%.3 Phacoemulsification is the most common cataract surgery technique performed4 and allows ophthalmologists to effectively emulsify and efficiently remove the eye's internal lens when it has become cloudy from cataracts5. It is a delicate procedure that requires significant effort and control during surgery, which can be taxing on the surgeon.
"While the phacoemulsification technique has been used successfully for decades, ease of use continues to be the unmet need with cataract surgeons," said Rajesh K. Rajpal***, MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs at Johnson & Johnson Vision. "Every aspect of Johnson & Johnson Vision's new VERITAS™ System was designed to give surgeons an excellent user experience – optimizing features for safety and efficiency, with improvements in two main areas: fluidics and ergonomics."
The VERITAS™ Vision System FDA clearance and CE mark further underscore Johnson & Johnson Vison's commitment to innovation and meeting the unmet needs of eye care professionals and patients. Last month, the company also announced the FDA approval of the TECNIS® EYHANCE6 and TECNIS® EYHANCE TORIC II intraocular lens (IOL)7 for the treatment of cataract patients in the United States. Both innovations come as the company celebrates the anniversary of its TECNIS® platform, the proprietary combination of materials and design on which the company's IOLs are built. The TECNIS® platform is responsible for two decades of breakthroughs in cataract treatment.
A full commercial launch of the VERITAS™ Vision System globally is expected later this year8.
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 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 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.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the VERITAS™ Vision System
Rx Only
INDICATIONS FOR USE: The VERITAS™ Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements
IMPORTANT SAFETY INFORMATION: Risks and complications of cataract surgery may include corneal burn. This device is only to be used by a trained licensed physician
ATTENTION: Reference the labeling for a complete listing of Indications and Important Safety Information
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VERITAS Vision System. 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 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; 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 December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
***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.
© Johnson & Johnson Vision 2021. All rights reserved.
1 Operator's Manual Z370584 Rev. E
2 Kellogg Eye Center. Cataract. https://www.umkelloggeye.org/conditions-treatments/cataract.
3 Vision Health Initiative, Common Eye Disorders. Centers for Disease Control and Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html
4 The Journal of the Missouri State Medical Association. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139750/
5 As with any medical procedure, risks and potential complications may occur. Please consult your eye care specialist for detailed information and to discuss these possible risks and complications with you prior to the procedure.
6 The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS® EYHANCE IOL which 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 is intended to be placed in the capsular bag.
7 The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS® EYHANCE TORIC II IOLs which are indicated for the visual correction of aphakia and pre-existing corneal astigmatism 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.
8 Disclaimer: Sales of products subject to registration and regulatory approval. Products might not be available in all EMEA countries.
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