Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses

VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform. This action was taken out of an abundance of caution after the company received reports of complications, the cause of which could not immediately be explained.

“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”

The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire, enVista Envy and certain enVista monofocal IOLs.

TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb responded quickly to treatment, and none have required removal of the lens.

“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”

Communications to eye care professionals are underway, with information on impacted lots and return protocols. Click here for a message from Saunders to customers, and here for a TASS fact sheet.

About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.