Bausch + Lomb identifies issue causing recall in enVista platform, returns product to market

The voluntary recall was originally in response to an increased number of reports of toxic anterior segment syndrome in the US in conjunction with the implantation of enVista Aspire and enVista Envy IOLs. Image credit: AdobeStock/Oktay

Bausch + Lomb announced it has identified the event that led to its recent voluntary recall¹ of intraocular lenses (IOLs) from its enVista platform and is moving forward with returning unaffected lots to market.²

The voluntary recall was originally in response to an increased number of reports of toxic anterior segment syndrome (TASS) in the US in conjunction with the implantation of enVista Aspire and enVista Envy IOLs, along with certain enVista monofocal lenses.

Bausch + Lomb announced it conducted a “thorough investigation” with the help of an unnamed “globally recognized TASS expert” as well as an advisory group of “nearly 30 top cataract surgeons, including American Society of Cataract and Refractive Surgery (ASCRS) leadership.”

The company noted that the result of the issue stemmed from raw material used in certain lots that was delivered by a different vendor. The company also noted that in response to the investigation, 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.

Full production of all enVista IOLs has resumed and, in the following weeks, will return to full market supply in the US. Market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities, according to the company.

Brent Saunders, chairman and CEO of Bausch + Lomb, commented on the recall and relaunch,² saying, “We voluntarily recalled these lenses because patient safety dictates every decision we make. 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.”

References:

1. Joy J. Bausch + Lomb voluntarily recalls select enVista IOLs. Optometry Times. Published March 27, 2025. Accessed April 24, 2025. https://www.optometrytimes.com/view/bausch-lomb-voluntarily-recalls-select-envista-iols

2. Bausch + Lomb Returning enVista® Intraocular Lenses to Market Following Voluntary Recall. Published April 24, 2025. Accessed April 24, 2025. https://www.bausch.com/newsroom/news/?id=256