Bausch + Lomb Resolves enVista IOL Recall Issue and Begins Product Relaunch

Bausch + Lomb has identified the root cause of a recent voluntary recall of select intraocular lenses (IOLs) from its enVista platform and is now moving forward with reintroducing unaffected lots to the market. The company announced that full production has resumed, and distribution will gradually scale across the U.S., with international reentry based on coordination with local health authorities.

Background on the enVista IOL Recall

The voluntary recall was initiated in response to increased reports of Toxic Anterior Segment Syndrome (TASS) associated with the use of:

       • enVista Aspire IOLs

       • enVista Envy IOLs

       • Select enVista monofocal lenses

TASS is a rare, non-infectious inflammatory condition affecting the anterior segment of the eye following intraocular surgery.

Investigation and Findings

According to Bausch + Lomb, a comprehensive investigation was conducted in partnership with:

       • A globally recognized TASS expert

       • An advisory group of nearly 30 leading cataract surgeons, including members of the American Society of Cataract and Refractive Surgery (ASCRS) leadership

The issue was traced to raw material variations—specifically, monomer components—used in certain product lots supplied by a different vendor. These deviations were determined to be the contributing factor in the increased TASS incidence.

Enhanced Quality Controls Implemented

In response to the findings, Bausch + Lomb has adopted the following corrective actions:

       • Enhanced inspection protocols for all enVista IOLs

       • More stringent standards for monomer preparation and raw material quality from vendors

These updates aim to prevent recurrence and ensure the highest safety standards for all enVista lens products.

Product Availability and Market Reentry

       • U.S. Market: Unaffected lots are being reintroduced, with full product supply expected in the coming weeks

       • International Markets: Market reentry will be evaluated case-by-case in collaboration with health authorities

Leadership Statement on Safety and Relaunch

“We voluntarily recalled these lenses because patient safety dictates every decision we make,” said Brent Saunders, Chairman and CEO of Bausch + Lomb. “We wouldn’t bring them back without full confidence in the enVista safety profile, which has been established over years and hundreds of thousands of implants.”

The enVista platform has been widely used for cataract surgery and is recognized for its clinical performance and safety.