Bausch + Lomb Recalls Certain enVista Intraocular Lenses

Bausch + Lomb announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.

This recall is in response to a growing number of reports of toxic anterior segment syndrome (TASS) related to implantation of enVista Aspire, enVista Envy and certain enVista monofocal IOLs. The company said the cause of these complications could not be immediately explained.

TASS is a possible complication in any cataract surgery. It’s an inflammatory reaction inside the eye that can have a variety of causes. When it happens, the complication usually appears 12-48 hours after eye surgery.

Bausch + Lomb said all enVista TASS cases reported to the company responded quickly to treatment and none required removing the lens.

“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”

The company said communications to eye care professionals are underway, with info on impacted lots and return protocols.

“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”

Earlier this month, the company launched its Arise orthokeratology lens fitting system in the U.S. Arise uses intelligent, cloud-based tech to streamline the orthokeratology lens design process.