FDA recalls OVD device
Posted on: Friday, 2 January 2009, 22:15 CST
The U.S. Food and Drug Administration has announced a Class I recall of certain Healon D ophthalmic viscosurgical devices.
OVDs are viscoelastic materials used to maintain space in the eye during surgery, the agency said Friday in a release.
Advanced Medical Optics of Santa Ana, Calif., issued a voluntary recall in October of all 4,439 units of Healon D lot number UD30654 after complaints of inflammation including Toxic Anterior Segment Syndrome. The company, however, said it has retrieved only 964 units of the 1,450 that had been distributed in the United States.
AMO said it received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin.
The FDA urges anyone in possession of any units from the recalled lot to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return.
Source: United Press International
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