AMO Healon D Recall: Cornea Transplant Product Linked to Eye Problems
The FDA has issued a Class I recall for one lot of Advanced Medical Optics, Inc. (AMO) Healon D, an ophthalmic viscosurgical device (OVD) used to maintain space in the eye during cornea transplant eye surgery and other procedures. The chemical agent has been linked to at least 66 reports of eye problems.
On October 30, 2008, AMO originally issued the eye surgery chemical agent recall for 4,439 units of Healon D, lot no. UD30654. The recall was issued after AMO receiving multiple complaints of inflammation following eye surgery, including reports patients developing Toxic Anterior Segment Syndrome (TASS).
The FDA indicates that as of December 3, 2008, AMO has only retrieved about two thirds of the recalled units distributed in the United States, leading the drug regulatory agency to re-issue the Healon D recall on January 2, 2008.
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Anyone with units from the recalled lot, whether the units were purchased or provided as a sample, are being urged by the FDA to remove them from their inventory due to the serious health risks posed.
AMO Healon D is typically distributed in pre-packaged syringes which are applied using a small tube during eye surgery procedures, such as corneal transplant surgery, secondary intraocular lens implantation, cataract surgery and glaucoma filtration surgery.
A Class I recall is the most serious type of recall, involving products which pose a reasonable probability of serious health problems or death if they continue to be used. Testing from this lot has revealed that the chemical agent contains elevated levels of endotoxin, which has been associated with the development of post-operative intraocular inflammation and TASS.
The eye inflammations have been observed within the first 12 to 24 hours after an eye surgery where the opthalmic viscosurgical device (OVD) was used. If the eye problems are treated promptly with topical corticosteroids, most individuals typically respond rapidly.
Advaned Medical Optics, Inc. previously faced severe criticism for their handling of a May 2007 contact lens solution recall, involving their multipurpose Complete MoisturePlus no-rub solution. Although the contact lens cleaner was linked to a substantially increased risk of a serious and potentially blinding eye infection known as Acanthamoeba keratitis, the company was accused of not taking enough steps to notify consumers and retailers of the recall.
Two months after the Complete MoisturePlus recall was issued, a CDC report indicated that less than a quarter of contact lens users were aware of the dangers. AMO was criticized for relying on press releases and government bulletins, instead of directly informing consumers and stores which stocked their products.
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