MedWatch: Class 1 Recall: Advanced Medical Optics, Inc. (EYE) Healon D Ophthalmic Viscosurgical Device (OVD)
12/11/2008 11:14:08 AM
[Posted 12/11/2008] Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes. Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome in patients following surgery. Healthcare professionals should stop using and remove from their inventory all units of the affected lot and contact AMO at 1-877-266-4543.