Bausch + Lomb Issues Voluntary Recall of Select enVista Intraocular Lenses

Bausch + Lomb has initiated a voluntary recall of specific intraocular lenses (IOLs) from its enVista platform, citing reports of post-operative complications. The decision, taken out of an abundance of caution, after the company received reports of complications.

“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, Chairman and CEO of 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.”

Reports of Toxic Anterior Segment Syndrome (TASS)

The recall was prompted by an increased number of reports of toxic anterior segment syndrome (TASS) in the U.S., observed following the implantation of:

       • enVista Envy IOLs

       • enVista Aspire IOLs

       • Select enVista monofocal lenses

TASS is a non-infectious inflammatory reaction within the anterior chamber of the eye and is a known but rare complication following cataract surgery. It typically presents 12–24 hours post-surgery. According to Bausch + Lomb, all reported cases responded well to treatment, and none required lens removal.

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

Communication with Eye Care Professionals Underway

Bausch + Lomb has begun direct outreach to eye care professionals, providing:

       • Detailed information on impacted lots

       • Return protocols for affected products

       • A letter from Brent Saunders to all affiliated providers

       • A comprehensive TASS fact sheet

The initial reports were associated with enVista Envy, but recent developments have extended concern to enVista Aspire and certain monofocal lenses, the company stated.

Ongoing Investigation and Expert Involvement

“We continue to test multiple lots and types of lenses and are carefully analyzing the reports to detect patterns or common factors,” Saunders wrote in the communication.

To guide its next steps, Bausch + Lomb is assembling a panel of cataract specialists to gain expert insights and help determine the best path forward for the enVista platform.