FDA Recalls Ophthalmic Viscosurgical Device

The Food and Drug Administration (FDA) has recently recalled an ophthalmic viscosurgical device (OVD) made by Advanced Medical Optics, Inc. (AMO). This is a Class I recall.

The recall is for lot no. UD30654 of Healon D. OVDs are used to preserve space in the eye during LASIK surgery. OVDs come in a syringe but are applied with a tube.

This past October, AMO voluntarily recalled 4,439 units from this particular lot of Healon D after patients were experiencing inflammations following their laser eye surgery procedure. The main condition caused by Healon D is Toxic Anterior Segment Syndrome (TASS), an inflammation of the front portion of the eye containing the cornea, iris, and lens.

Despite the voluntary recall, AMO had only recovered less than 1,000 of the defective units by early December. So far, there have been 66 patients reporting complications related to the Healon D product.

If you have any of the Healon D units from the recalled lot, contact AMO immediately at 1-877-AMO-4Life to find out about proper recall procedure. You can find the lot number on the side panel of the unit.

You can also report any complications or adverse side effects associated with the Healon D product to the FDA's MedWatch Event Reporting program.