FDA announces class 1 recall of single lot of Healon D
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The U.S. Food and Drug Administration has announced a class 1 recall of a single lot of Advanced Medical Optics' Healon D ophthalmic viscoelastic device, according to a press release from the agency.
This follows AMO's voluntary recall of all 4,439 units of Healon D lot No. UD30654 in October following complaints of postoperative ocular inflammation, including toxic anterior segment syndrome (TASS). In all, the company obtained 66 adverse event reports associated with the recalled product. Tests of this lot revealed elevated endotoxin levels, which have been linked to postoperative intraocular inflammation and TASS.
While AMO notified customers of the adverse events associated with Healon D from that lot at the time of the initial recall, AMO had recovered only 964 of the 1,450 units that had been distributed in the United States as of Dec. 3, the release said.
The FDA recommends that anyone in possession of units from the recalled lot remove them from inventory and contact AMO at 1-877-AMO-4Life to arrange return of the product to the company.
Class 1 recalls are for products that the FDA deems dangerous or defective and could cause serious health problems or, in some cases, death, according to literature on the agency's Web site.