FDA Recall of Ophthalmic Surgical Device
Posted by
Jessica SmagaczJanuary 05, 2009 12:07 PMFDA announced a recall on January 2 of UD 30654 of Healon D, an ophthalmic viscosurgical device (OVD). This device is manufactured by Advanced Medical Optics Inc. of Santa Ana, California.
On October 30, 2008, Advanced Medical Optics Inc. voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D. They recalled this product because they received complaints of inflammation after eye surgery including Toxic Anterior Segment Syndrome (TASS).
OVDs, FDA explains, are viscoelastic materials that are used to maintain space in the eye during surgery. They are typically applied using a small tube.
When the company initially recalled these products, they informed customers of the number and nature of the adverse event reports associated with the product.
By December 2, 2008, Advanced Medical Optics Inc. retrieved only 964 units out of the 1,450 distributed in the US.
Advanced Medical Optics Inc. received 66 adverse event reports associated with OVD! Tests were completed on these products and they revealed elevated levels of endotoxin (associated with post-operative intraocular inflammation and TASS). TASS is an acute inflammation of the eye that occurs after operation.
FDA is urging anyone who has possession of these units to remove them from inventory and contact Advanced Medical Optics Inc. at 1-877-AMO-4Life in order to make arrangements for return.