Bausch + Lomb Cataract Lenses Recalled Amid Reports of Severe Eye Inflammation Side Effects

Manufacturer is recalling all enVista Aspire and Envy lenses, as the cause of adverse reactions among patients remains unclear.

A voluntary recall of all Bausch + Lomb enVista Aspire and Envy lenses has been initiated by the manufacturer, following multiple reports of eye inflammation in patients after surgery.

Bausch + Lomb announced the enVista Envy and Aspire recall (PDF) on March 27, following an increase in reports of eye surgery patients suffering from toxic anterior segment syndrome (TASS) after being implanted with the lenses.

TASS is a rare, non-infectious inflammatory reaction that can affect the front part of the eye following surgical procedures, including cataract surgery. It is triggered by the introduction of harmful substances into the eye during or after the operation and usually appears 12 to 48 hours after treatment.

If not addressed quickly, TASS can result in serious complications, such as irreversible corneal damage, the development of glaucoma or loss of vision.

Over the past few weeks, Bausch + Lomb has received an increasing number of reports of TASS in patients who were implanted with enVista intraocular lenses (IOLs). Although the initial reports centered upon enVista Envy lenses, more recently enVista Aspire and monofocal lenses have also been associated with adverse reactions.

All of the cases of TASS associated with the affected lenses have responded well to treatment and have not required removal of the lens.

However, the manufacturer has not been able to identify the root causes of TASS in the affected patients. For this reason, the company has chosen to recall all enVista Envy and Aspire lenses as well as some monofocal lens lots across the U.S.

Bausch + Lomb is testing different lots and types of lenses to determine the cause of the reaction, and is analyzing patterns for common factors. It has also reached out to a group of cataract specialists to help determine the best path forward.

In the coming days, the company expects to send out instructions for healthcare providers regarding how they should handle any remaining stock they have in inventory.

“As much as we believe in the enVista platform, patient safety will always be our number one priority,” Bausch + Lomb Chairman and CEO, Brent Saunders, said in the recall notice. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”

Customers who have concerns about Bausch + Lomb enVista lenses or would like to report an adverse event can contact the company’s Customer Care team at (800) 338-2020, option 9.