Bausch + Lomb points recall of enVista lenses utilized in cataract surgical procedure

Bausch + Lomb has introduced a voluntary recall of intraocular lenses on its enVista platform because of the potential for an acute postoperative inflammatory response.

All a number of 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 reviews of poisonous anterior phase syndrome, or TASS, an acute sterile anterior chamber inflammatory response that normally develops 12 to 48 hours after surgical procedure. All sufferers with reported circumstances of TASS because of the enVista lenses responded rapidly to remedy. No sufferers wanted to have the lenses eliminated. Bausch + Lomb remains to be investigating the reason for the issues reported.

“As a lot as we consider within the enVista platform, affected person security will all the time be our primary precedence. Surgeons and sufferers belief Bausch + Lomb, and I consider that this voluntary recall is the perfect factor we are able to do to honor that belief,” Brent Saunders, chairman and CEO of Bausch + Lomb, stated in an announcement. “These reviews symbolize only one to 2% of implanted lenses, with a constructive prognosis for everybody concerned. We sit up for figuring out a root trigger and bringing the enVista platform again 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 a minimum of 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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