Bausch + Lomb announced it has identified the event that led to its recent voluntary recall of intraocular lenses (IOLs) on the enVista platform. Now that the cause and affected lots have been confirmed, the company will return these models to market, the company said in a press release. 

“We voluntarily recalled these lenses because patient safety dictates every decision we make,” said Brent Saunders, chairman and CEO, Bausch + Lomb, in the press release. “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.”

Investigation Results

After a thorough investigation with the help of a globally recognized toxic anterior segment syndrome (TASS) expert and an advisory group of nearly 30 top cataract surgeons including American Society of Cataract and Refractive Surgery leadership, the company determined that the issue stemmed from raw material used in certain lots that was delivered by a different vendor. The tight correlation between the lots in question and reported TASS cases is clear, as highlighted in the recall timeline.

Bausch + Lomb said it continues to share its findings with the US Food and Drug Administration (FDA) and other regulatory authorities.

Enhanced Procedures and Return to Market

In response to the investigation, Bausch + Lomb said it has implemented enhanced inspection protocols for IOLs, as well as more explicit standards for how the monomers that make up its lenses are prepared by vendors.

With these new processes in place, Bausch + Lomb said it has returned to full production of all enVista IOLs. In the following weeks the company will return to full market supply in the United States; timing for market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities.

See a message from Saunders to customers and TASS fact sheet for additional information. Bausch + Lomb said it will discuss financial impacts of the voluntary recall on its April 30 first-quarter earnings call.