Brent Saunders: Bausch + Lomb to Return enVista IOLs to Market Following Voluntary Recall

Bausch + Lomb announced it has identified the event that led to its recent voluntary recall of IOLs on the enVista platform, Brent Saunders, chairman and CEO, Bausch + Lomb, confirmed to Eyewire News. Now that the cause and affected lots have been identified, the company will return these models to market.

After consultation with experts, Bausch + Lomb 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 stated.

"Today we are pleased to announce that we are returning to market with our Envista Platform in the United States, and in the coming weeks based on our regulatory approval, around the world. This follows a recall that we announced about a month ago related to elevated cases of TASS associated with the Envista Platform," Mr. Saunders said to Eyewire News. "After intensive interrogation and investigation, consultation with many KOLs, TASS experts, and other experts, and really working through the problem, we did identify a deviation from a supplier. And as a result, we have enhanced our process to make sure that our monomers are validated and our interrogation of lenses is enhanced. We have great confidence in our return to market plan, and we look forward to working with the surgical community and serving patients with high-quality products for the future." 

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 US; timing for market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities.

Mr. Saunders posteed this message to customers. Bausch + Lomb will discuss financial impacts of the voluntary recall on its April 30 first-quarter earnings call.

Bausch + Lomb continues to share its findings with the FDA and other regulatory authorities.