Lenses used in eye surgeries recalled until company knows ‘exactly what’s going on,’ CEO says

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A popular provider of eye care products is recalling several types of artificial lenses in Canada, noting reports of inflammation it says “could not immediately be explained.”

Bausch + Lomb issued a voluntary recall south of the border late last month of a number of lenses designed to be implanted in the eye for the treatment of vision issues including cataracts. The company confirmed to CTVNews.ca in an email Thursday that the recall also applies to some products in Canada.

The recall affects the following:

• enVista monofocal lenses with model numbers beginning with EE (non-toric monofocal) and ETE (toric monofocal);
• all models of enVista Envy; and
• all models of enVista Envy Toric.

The recall was triggered by reports of toxic anterior segment syndrome (TASS), an inflammatory reaction that typically occurs after cataract surgery. A handout provided by Bausch + Lomb about TASS says, “It is caused by toxic substances entering the eye during surgery, leading to acute inflammation but no infection.”

In this case, the company said in a news release, TASS has been reported in people who had recently had Bausch + Lomb lenses implanted.

In a statement, chairman and CEO Brent Saunders said the “root cause of these cases is unclear.” The company recalled the products “until we have a better understanding of exactly what’s going on.”

Saunders said those who developed TASS were treated, and the lenses did not need to be removed. He said the cases represented only an “extremely small percentage” of implanted lenses.

Symptoms of TASS include redness, swelling and pain, clouded vision, and dilated, irregular or non-reactive pupils, as well as pressure in the eyes that can lead to secondary glaucoma, the company’s fact sheet says.

Treatment typically involves a high dose of corticosteroids, medication or eye drops to prevent the iris from sticking to the lens, and monitoring for complications including corneal damage and glaucoma.

Most cases are healed within a few days of treatment, Bausch + Lomb says, but severe cases can lead to permanent damage or vision loss.