FDA Announces Class I Recall of Ophthalmic Surgical Device

FOR IMMEDIATE RELEASE
January 2, 2009

Media Inquiries:
Siobhan DeLancey, 301-796-4668
Consumer Inquiries:
888-INFO-FDA

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

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