Bausch + Lomb Corporation 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.
“We voluntarily recalled these lenses because patient safety dictates every decision we make,” said Brent Saunders, chairman and CEO, 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.”
Investigation results
After a thorough investigation in collaboration with 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 continues to share its findings with the U.S. Food & Drug Administration and other regulatory authorities.
Enhanced procedures and return to market
In response to the investigation, Bausch + Lomb 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 has returned to full production of all enVista IOLs.
In the following weeks the company will return to full market supply in the U.S.; 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 will discuss financial impacts of the voluntary recall on its April 30 first-quarter earnings call.