The FDA elevated a recall of intraocular lenses currently being wrapped up by Bausch + Lomb, following increased reports of inflammatory reactions from patients who underwent cataract surgery.
The company first announced it would begin pulling certain models of its enVista implants in late March and early April, including its Aspire and Envy toric and non-toric lenses, as well as monofocal versions.
“As much as we believe in the enVista platform, patient safety will always be our number one priority,” CEO Brent Saunders said in a statement at the time. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”
After relaying the company’s announcement in early April, the FDA recently gave the recall a Class I designation, its most serious.
The company said it had recorded a higher-than-expected number of cases of toxic anterior segment syndrome, which can happen after any cataract surgery. TASS is an acute inflammatory reaction that develops within the fluid-filled chamber between the eye’s cornea and iris. It typically occurs within 12 to 48 hours after the procedure, causing redness and swelling, and responds to steroid treatments.
“These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved,” Saunders said in the April 3 statement. The company said no patients needed to have their intraocular lenses removed, and that “only a handful involved intervention beyond standard of care.”
In an April 30 filing with the SEC, the company said it had completed its investigation into the root cause of the issue late last month, and that it stemmed from raw materials used in certain lots obtained from a different vendor.
Bausch + Lomb subsequently narrowed the scope of the recall on May 1, and has returned to full production with revised manufacturing and inspection standards, with plans to return to full U.S. market supply within weeks.
Bausch + Lomb and the FDA had urged healthcare professionals to quarantine their affected enVista lenses and to closely monitor cataract patients for at least two days after surgery—while instructing patients to contact their providers immediately with any new or worsening symptoms.
If TASS is left untreated, severe complications can include glaucoma and vision loss. The agency estimated that about 285,000 affected lenses were distributed in the U.S. and worldwide.
The enVista Aspire monofocal and toric lenses launched in the U.S. in October 2023, while the Envy is currently being rolled out. The company said it plans to launch the enVista Beyond, with an extended depth of focus, in the U.S. in 2026.