Alex Young , 2025-04-24 14:27:00
April 24, 2025
1 min read
Key takeaways:
- Bausch + Lomb conducted an investigation and identified the cause and affected lots of the IOLs.
- Full market supply will return to the U.S. within weeks.
Editor’s note: This is a developing news story. Please check back soon for updates.
Bausch + Lomb will return its enVista IOLs to market after identifying the event that led to a voluntary recall, according to a press release.
Bausch + Lomb will return its enVista IOLs to market after identifying the event that led to a voluntary recall.
The company recalled the lenses in March after receiving reports of toxic anterior segment syndrome (TASS) among patients implanted with the IOLs in the U.S.
Bausch + Lomb conducted an investigation with the help of nearly 30 cataract surgeons, including leaders from the American Society of Cataract and Refractive Surgery, and found that raw material used in certain lots was delivered by a different vendor.
The correlation between the affected lots and reported cases of TASS “is clear,” according to the release.
In light of the investigation’s findings, Bausch + Lomb has implemented new inspection protocols for IOLs, as well as more stringent standards for how raw materials for the lenses are prepared by vendors.
The company has restored production of all enVista IOLs and expects to return to full market supply in the coming weeks, according to the release.
“We voluntarily recalled these lenses because patient safety dictates every decision we make,” Brent Saunders, Bausch + Lomb’s chairman and CEO, said in the 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.”
