Eye health company Bausch & Lomb is recalling some of its intraocular lenses over possible safety concerns.
The voluntary recall comes after the company “received reports of complications, the cause of which could not immediately be explained,” Bausch & Lomb said in a March 27 release.
The recall affects the company’s enVista Aspire and enVista Envy lenses, as well as some enVista monofocal lenses in the U.S.
These are types of artificial lenses that are implanted in the eye to aid vision following cataract surgery.
According to Bausch & Lomb, there was an “increased number” of reports of toxic anterior segment syndrome (TASS) connected to the implantation of certain enVista lenses.
TASS is an inflammatory reaction caused by toxic substances entering the eye. Symptoms can include redness, swelling and pain, as well as clouding of the eye or abnormalities of the pupil, according to a TASS fact sheet shared by Bausch & Lomb.
In some cases, symptoms of TASS can include increased fluid pressure within the eye. This, in turn, can cause secondary glaucoma, a condition that damages the optic nerve, according to the American Academy of Ophthalmology.
TASS often occurs within 12 to 48 hours after eye surgery, though onset of the condition can be delayed days or weeks. It may be linked to “foreign materials” introduced during surgery, or “intraocular lens reactions,” according to Bausch & Lomb.
Most cases of TASS can be treated with steroids within a few days, although severe cases can lead to permanent damage to the cornea, the clear, outermost layer of the eye. Severe cases can also lead to glaucoma or vision loss, according to the company’s TASS fact sheet.
All the TASS cases associated with enVista Aspire and Envy lenses “responded quickly to treatment” and did not require removal of the lens, Bausch & Lomb says.
“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” CEO Brent Saunders said in a statement. “We look forward to identifying a root cause and bringing the enVista platform back to market.”
In a letter Thursday to health care providers, Saunders said the company will be sending out detailed instructions in the coming days about what to do with any existing stock of enVista products.
In the meantime, if you believe you have been affected by this recall or have any concerns, contact your eye care provider.
