FDA Recalls Eye-Surgery Device

WASHINGTON — Federal regulators are recalling the Healon D Opthalmic Viscosurgical Device made by Advanced Medical Optics Inc. after some physicians said patients have seen inflammatory reactions after eye surgery. The FDA attributes it to contamination.

The recall involved one lot of 30 mg/mL fill size syringes, labeled with “Lot Number UD30654 AMO Healon D Ophthalmic Viscosurgical Device.”  The device was made from Sept. 1-30, 2008 and distributed from Sept. 1 to Oct. 29, 2008. 

This is not the first time a product by the Santa Ana, Calif.-based company has been recalled for contamination problems. Between 2006 and 2007, AMO issued two recalls some of its Complete MoisturePlus products. In some cases, these recalled products caused serious eye infections, leading to permanent injury for some victims. 

According to the FDA, the AMO Healon D OVD is intended for intraocular use as a surgical aid in the following ophthalmic surgical procedures: 

•    cataract surgery, with or without an intraocular lens

•    corneal transplant surgery

•    glaucoma filtration surgery, and secondary intraocular lens implantation 

According to the FDA, the AMO Healon D OVD recall was initiated after testing revealed the product had endotoxin levels above the required limit.