Bausch + Lomb voluntarily recalls select enVista IOLs

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Bausch + Lomb has announced a voluntary recall of intraocular lenses (IOLs) from its enVista platform, an action taken out of an abundance of caution after the company received reports of complications.¹ The cause of said complications could not be immediately explained, according to a news release.

“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, in the release. “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 recall is in response to an increased number of reports of toxic segment syndrome (TASS) in the US in conjunction with the implantation of enVista Aspire and enVista Envy IOLs, along with certain enVista monofocal lenses. TASS is an inflammatory reaction inside the eye that can have a variety of causes, but is also a potential complication in any cataract surgery. When TASS is caused by eye surgery, the complication typically appears 12-24 hours after the procedure. All enVista TASS cases reported to Bausch + Lomb responded quickly to treatment, and none have required removal of the lens.¹

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

Communications by Bausch + Lomb to eye care professionals are underway, which includes providing information on impacts lots and return protocols. The company is distributing a letter from Saunders to be sent to eye care providers who conduct business with Bausch + Lomb, along with a TASS fact sheet.¹

In the letter, Saunders noted that initial TASS reports were centered on enVista Envy, “but in recent days have extended to include enVista Aspire and enVista monofocal lenses.”²

“We continue to test multiple lots and types of lenses, and we’re carefully analyzing the reports to detect patterns or common factors,” Saunders wrote in the letter.² “In addition, we’re convening a group of cataract specialists to understand their perspectives and help us chart the best path forward.”

References:

1. Bausch + Lomb announces voluntary recall of enVista Aspire, enVista Envy, and certain enVista monofocal intraocular lenses. News release. Bausch + Lomb. March 27, 2025. Accessed March 27, 2025. https://www.bausch.com/newsroom/news/?id=254

2. Saunders B, Bausch + Lomb. enVista customer letter. March 27, 2025. Accessed March 27, 2025. https://www.bausch.com/globalassets/pdf/pr/brent-saunders-envista-customer-letter-final.pdf