Bausch + Lomb (B+L) has confirmed a 27 March 2025 voluntary recall only relates to the new enVista Envy intraocular lens (IOL) in the Australia and New Zealand region.
It comes after the company announced a recall of IOLs on its enVista platform, a move “taken out of an abundance of caution” after reports of complications, the cause of which could not immediately be explained.
It relates 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.
While the recall affects multiple IOL lenses in other countries, B+L’s ANZ business said it was limited to the enVista Envy in Australia and New Zealand, which only became available in recent months.
For example, the enVista monofocal is part of the recall overseas but those lenses are still safe to use in Australia and New Zealand, due to it being a different model.
“We look forward to addressing this situation as soon as possible and being able to provide the enVista Envy again, to surgeons and patients across Australia and New Zealand,” B+L ANZ business manager Mr Chad van Staden said.
The company’s chairman and CEO Mr Brent Saunders said: “As much as we believe in the enVista platform, patient safety will always be our number one priority.
“Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honour that trust.”
A letter Sounders wrote to eyecare professional customers can be found here.
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, it typically appears 12-48 hours after eye surgery.
All enVista TASS cases reported to B+L responded quickly to treatment, and none have required removal of the lens, the company reported.
“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Saunders said.
“We look forward to identifying a root cause and bringing the enVista platform back to market.”
Communications to eyecare professionals are underway, with information on impacted lots and return protocols.
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