After Recalling Complete MoisturePlus, AMO Recalls Healon D
Posted by
Armand RossettiJanuary 13, 2009 2:10 PM
In 2007, Advanced Medical Optics (AMO) was in the headlines because the FDA had announced a recall of AMO's Complete MoisturePlus contact lens solution due to a high incidence of Acanthamoeba infections. This past week, the FDA announced a Class I recall on AMO’s Healon D ophthalmic viscosurgical device.
Reportedly, the FDA announced a Class I recall of AMO's new surgical device, which involved 4,439 units. Healon D is one of a family of a viscoelastic products, prepackaged in a syringe and applied in the eye during surgery to maintain spacial integrity and prevent collapse.
In its January 2, 2009 announcement, the FDA indicated that it had received 66 adverse event reports associated with the product, and that testing revealed elevated levels of endotoxin, which was associated with post operative intraocular inflammation and Toxic Anterior Segment Syndrome (TASS). Earlier in December 2008, AMO reported that it had retrieved 964 units and had accounted for most of the 1,450 units distributed in the United States.
It was only recently on October 8, 2008, that AMO received FDA Premarket Approval (PMA) for Healon D for use during cataract extraction, intraocular lens implantation, corneal transplant and glaucoma filtration surgery. By obtaining FDA approval, AMO received an opportunity to combination package Healon D with a higher molecular weight material called Healon GV, and existing standard Healon products.
In an effort to become a global leader in vision, Abbott has recently acquired AMO in principal for 2.8 billion dollars, and Abbott will be making a tender offer for AMO’s outstanding shares on January 26, 2009. Thereafter, AMO’s Chairman, Jim Mazzo, will be remaining with Abbott as AMO’s President.