FDA recalls OVD after TASS reports

Rockville, MD

-The FDA has recalled one lot of an ophthalmic viscosurgical device ([OVD] Healon D, Advanced Medical Optics [AMO]) following a voluntary recall by the manufacturer. The lot number, UD30654, is displayed on the side panel of each unit.

AMO voluntarily recalled all 4,439 units of the lot Oct. 30 after receiving complaints of inflammation after eye surgery, including toxic anterior segment syndrome (TASS). At that time, the company informed customers of the lot number and nature of adverse event reports and included a fax reply form for communication with the firm. As of Dec. 3, however, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States, according to the FDA.

AMO received 66 adverse event reports associated with the recalled product. Tests of the lot revealed elevated levels of endotoxin.

The FDA urges anyone possessing any units from the recalled lot to remove them from inventory and contact AMO at 877/AMO-4Life to make arrangements to return them to the company. Health-care professionals and consumers may report serious adverse events or product quality issues associated with the use of this product to AMO by calling the aforementioned telephone number or by contacting the FDA’s MedWatch Adverse Event Reporting program online at

www.fda.gov/MedWatch/report.htm

; by mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787; by fax to 800/FDA-0178; or by phone to 800/FDA-1088.