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FDA Issues Warning on Sterilizer

April 3, 1998

WASHINGTON (AP) _ Hospitals and eye doctors should avoid using a medical sterilizer believed responsible for some vision-crippling eye injuries, the Food and Drug Administration says in an urgent warning.

Illinois-based Abtox Inc. began recalling 155 Abtox Plazlyte Sterilization Systems sold around the country, in addition to sterilizers sold abroad.

To be certain U.S. hospitals got the message, the FDA issued its own warning Thursday that hospitals that own the system should stop using them, should not use any eye instruments previously sterilized on them and should alert ophthalmologists to check on their patients.

The FDA never approved the machines, said Dr. Bruce Burlington, the FDA’s medical device chief.

The problem appears to be confined to sterilization of cataract surgery equipment, he said.

Somehow, the sterilizing chemicals interfere with nonferrous metals in the surgical instruments to produce toxic mineral salts. Those salts damage the cells responsible for pumping water out of the eye’s cornea, Burlington explained.

If the cells do not work properly, the cornea gets clouded, blisters appear and vision can be so damaged that glasses can’t help and people need corneal transplants, he said.

The FDA knows of 10 patients who have suffered corneal damage following the cataract surgery, including two who so far have had corneal transplants. It is following up on unconfirmed reports of another half dozen cases, Burlington said.

However, Burlington said most cataract patients will not have to worry: Cataract surgery is done in hundreds of hospitals, but only 155 unapproved sterilizers were sold here.

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