Class I Recall of Eye Surgery Product Healon D

The FDA has recalled lot number UD30654 of Healon D, which is an ophthalmic viscosurgical device (OVD). Healon D is manufactured by Advanced Medical Optics, Inc. (AMO) of Santa Ana, California. Though all units of the affected lot number had been voluntarily recalled by AMO on October 30, 2008, the company has not received all of the units distributed in the United States. The recall was spurred by complaints of patients suffering inflammation following eye surgery. Some patients suffered Toxic Anterior Segment Syndrome (TASS). During eye surgery, OVD’s, like Healon D are used to maintain space in the eye. Anyone who has any unit from the recalled lot of Healon D should remove that unit from their inventory and contact AMO at 1-877-AMO-4Life to return the product.