Bausch + Lomb today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform. In a press release, Bausch + Lomb stated that this action was taken out of an abundance of caution after the company received reports of complications, the cause of which could not immediately be explained.
“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, Bausch + Lomb, in the press release. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”
The company said the recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire, enVista Envy and certain enVista monofocal IOLs.
All enVista TASS cases reported to Bausch + Lomb responded quickly to treatment, and none have required removal of the lens, the company noted.
“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Mr. Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”
The company said communications to eyecare professionals are underway, with information on impacted lots and return protocols. Click here for a message from Mr. Saunders to customers, and here for a TASS fact sheet.