FDA Warns Abbott Unit Over Eye Device Manufacturing

Law360, New York (December 16, 2009, 4:27 PM EST) -- The U.S. Food and Drug Administration has warned an Abbott Laboratories subsidiary that it violated manufacturing practices for its ophthalmic viscoelastic devices, which are used during eye surgery.

The Swedish unit failed to perform and document cleaning of equipment used to produce the Healon D ophthalmic devices, in violation of the Federal Food, Drug and Cosmetic Act, the FDA said in a letter that was released Tuesday and dated Sept. 18.

The letter was addressed to Advanced Medical Optics Uppsala AB, a Swedish company that became...
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