FDA Warns of Faulty Manufacturing at Abbott Eye-Device Plant

The Food and Drug Administration has warned a subsidiary of Abbott Laboratories about violations of manufacturing practices uncovered at an eye-device plant in Sweden.

The company, Advanced Medical Optics, did not properly clean manufacturing equipment used to make Healon D ophthalmic viscoelastic devices, according to the FDA warning letter. The company was acquired by Abbott earlier this year and renamed Abbott Medical Optics Inc., according to a Reuters news report.

Ophthalmic viscoelastic devices are used during cataract surgery to maintain space in the eye. They usually come pre-packaged in a syringe and are applied using a small tube.

A March 2009 FDA inspection of the plant in Uppsala, Sweden found some of the devices were adulterated and did not conform to FDA manufacturing practices, officials said.

The FDA said two responses Abbott sent the agency after the warning letter were “inadequate” because the company indicated it does not plan to improve its cleaning processes for at least a year, when a recall of eye devices is done.

One lot of Healon D devices made at the Sweden plant were recalled earlier this year after high levels of endotoxin, which can cause inflammation, were found in some of the products, officials said.

Eye infections can have sever health consequences, including irritation, reduced vision, and even blindness.

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