Ophthalmic viscosurgical device recalled by FDA after reports of toxic anterior segment syndrome

Key Points

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. FDA spokeswoman Siobhan DeLancey said the FDA characterizes the action as a Class I recall because the lot poses a "significant potential for harm to human health." The delayed classification merely restates the company's voluntary recall, she said.