After receiving reports that a few U.S. physicians observed an inflammatory reaction in some patients at the one-day post-operative visit, Advanced Medical Optics is voluntarily recalling a specific lot number of Healon D viscoelastic.
Product code: 10204011
Description: 30mg/mL, 0.65 mL fill size
Lot number: UD30654
This lot is being recalled because endotoxin levels above specification have been noted in some syringes tested, says AMO in a recall letter. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS (toxic anterior segment syndrome) in patients following surgery, says AMO.
AMO received FDA approval for Healon D viscoelastic last month.
"While AMO has received limited reports, the company elected to proceed aggressively to minimize the potential impact on its customers and their patients and initiated a voluntary recall of the specific lot," says AMO in a prepared statement. "AMO has notified all customers in possession of the specific lot of Healon D viscoelastic, and will be notifying the U.S. Food and Drug Administration (FDA)."
AMO says it has located and removed from inventory the single lot of Healon D viscoelastic in question. The company adds that all other Healon viscoelastic products are unaffected by this action. Healon D viscoelastic has been available in Europe since July of this year and has not experienced a similar issue, says AMO.
—Dan O’Connor
