Instant Report

Date: 23-Apr-2021

Johnson & Johnson Vision Gets US FDA 510(k) Clearance And CE Mark For Next-generation Phacoemulsification Machine, VERITAS Vision System

Johnson & Johnson Vision, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies, announced the FDA 510(k) clearance and CE mark of its next-generation phacoemulsification innovation, the VERITAS Vision System. The high-performance phacoemulsification system features technologies that allow surgeons to guide through any lens density with fewer surges 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, and cataract surgery is one of the most common outpatient procedures performed today with a success rate of approximately 98%. 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 cataracts. 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) 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 is built. The TECNIS platform is responsible for two decades of breakthroughs in cataract treatment.