Bausch + Lomb has reported a “voluntary recall” of certain intraocular lenses (IOLs) on its enVista platform due to complications.
This decision was made following an increase in the number of toxic anterior segment syndrome (TASS) cases reported in the US, which are associated with the implantation of enVista Envy IOLs, enVista Aspire, and some enVista monofocal lenses.
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According to the company, TASS is an inflammatory reaction within the eye that can arise from several causes and usually manifests within 12 to 48 hours post-eye surgery. This condition is also stated to be a cataract surgery complication.
Bausch + Lomb noted that all reported instances of TASS related to its enVista have been responsive to treatment, with no cases necessitating lens removal.
The company is currently communicating with eye care professionals to provide details on the affected lots and the protocols for returning.
Bausch + Lomb CEO and chairman 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.”
“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved. We look forward to identifying a root cause and bringing the enVista platform back to market.”
Last May, the company announced the receipt of Health Canada’s regulatory approval for the enVista Envy full visual range IOL.
In October 2023, the company launched the enVista Aspire monofocal and toric IOLs with Intermediate Optimised optics in the US.
Founded in 1853, Bausch + Lomb has a portfolio of 400 products spanning eye care, contact lenses, ophthalmic pharmaceuticals, ophthalmic surgical devices, and instruments, as well as over-the-counter products.
