Bausch + Lomb has introduced a voluntary recall of intraocular lenses on its enVista platform as a result of potential for an acute postoperative inflammatory response.
All numerous the next intraocular lens fashions in the USA are included within the recall: enVista Aspire, enVista Aspire Toric, enVista Envy, and enVista Envy Toric, in addition to enVista monofocal and enVista monofocal Toric.
The recall was issued in response to stories of poisonous anterior section syndrome, or TASS, an acute sterile anterior chamber inflammatory response that normally develops 12 to 48 hours after surgical procedure. All sufferers with reported instances of TASS as a result of enVista lenses responded rapidly to therapy. No sufferers wanted to have the lenses eliminated. Bausch + Lomb continues to be investigating the reason for the issues reported.
“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 honor that trust,” Brent Saunders, chairman and CEO of Bausch + Lomb, mentioned in a press release. “These reports represent only 1 to 2% 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.”
Sufferers who’ve undergone cataract surgical procedure ought to contact their eye care skilled instantly in the event that they expertise eye discomfort. In the meantime, eye care professionals ought to proceed to carefully monitor cataract surgical procedure sufferers for not less than 48 hours after surgical procedure and instruct sufferers to name the workplace instantly in the event that they develop new or worsening signs.
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Bausch + Lomb points recall of enVista lenses utilized in cataract surgical procedure (2025, April 10)
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