B + L enVista Envy IOL recall in NZ

New Zealand distributor Toomac Ophthalmic confirms Bausch + Lomb’s 27 March 2025 voluntary recall only concerns the enVista Envy intraocular lens (IOL) in this market.

The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the US.

“This has in no way impacted enVista monofocal IOL’s in New Zealand as the model we sell here is different to the model in the US. Commercial activities relating to the enVista Envy commenced in March 2025, though there were some pre-launch implantations. Results have been excellent with no incidence of TASS in New Zealand,” said Graham Brown, Toomac national territory manager.

“It’s important to point out that this was a voluntary recall in an overabundance of caution. An action that has been very positively received by customers who have praised this proactive response,” according to Brown.

TASS, a potential complication in any cataract surgery, is 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. All enVista TASS cases reported to Bausch + Lomb responded quickly to treatment, and none have required removal of the lens, the company said.

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

New Zealand ECPs have been informed, by Toomac in conjunction with Medsafe, and will be updated when further details are available, Brown said.