J&J’s Veritas Vision System Receives FDA Clearance and CE Mark

Johnson & Johnson Vision, part of the Johnson & Johnson Medical Devices Companies, has received FDA 510(k) clearance and a CE mark for 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.
 
A full commercial launch of the Veritas Vision System globally is expected later this year⁸.
 
References:
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.