Bausch & Lomb will recall some intraocular lenses after receiving reports of inflammatory reactions, the cause of which is not currently known.
The company said it is recalling the lenses, which are part of its enVista platform, out of an abundance of caution, and is looking to identify a root cause. "As much as we believe in the enVista platform, patient safety will always be our number one priority," said CEO Brent Saunders in a press release.
Patients responded quickly to treatment, and none required lens removal
The company said it is informing eye care professionals about the impacted lots and return protocols for the product.
The intraocular lenses (IOLs) or surgically implanted lenses are used in cataract surgery to replace the natural clouded lens in the eye.
As of April 7, 2024, the FDA has released more information on the lenses and the cases of inflammation. Affected IOLs are all lots of enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S., they reported.
According to the FDA, cases of inflammation were toxic anterior segment syndrome (TASS), which is "a potential complication in any cataract surgery, [and] an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery." Again, no cases have required lens removal.
“These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued in the FDA statement. “We look forward to identifying a root cause and bringing the enVista platform back to market.”
Sources:
Reuters. Bausch + Lomb recalls some of its implantable eye lenses. March 27, 2025. Accessed March 27, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/bausch-lomb-recalls-some-its-implantable-eye-lenses-2025-03-27/
FDA. Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S. April 7, 2025. Accessed April 10, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar
