Bausch + Lomb announced plans to bring its recalled enVista intraocular lenses (IOLs) back to the market after resolving the issue that led to a voluntary recall last month. The recall, which affected enVista Aspire, enVista Envy, and certain enVista monofocal IOLs, was initiated following an increase in cases of toxic anterior segment syndrome (TASS).
Following a thorough investigation, the company determined that the issue stemmed from raw material used in certain lots, supplied by a different vendor. Enhanced inspection protocols and stricter standards for vendor preparation have been implemented. Bausch + Lomb is confident in the safety profile of the enVista IOLs and has resumed full production, with plans to return to U.S. market supply soon. The company is working with health authorities for a case-by-case reentry into other markets.
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