Alerts
Advanced Medical Optics Recall - Healon D Ophthalmic Viscosurgical Device
December 12, 2008
Advanced Medical Optics and the FDA have issued a Class I recall of one lot of Healon D Ophthalmic Viscosurgical Device, 30 mg/mL fill size syringes (lot number UD30654, manufactured between September 1, 2008 and September 30, 2008). The device is being recalled due to higher than allowed endotoxin levels found in some of the tested syringes. This device is used as a surgical aid during anterior segment surgeries. High endotoxin levels may cause intraocular inflammation or Toxic Anterior Segment Syndrome. An inflammatory reaction has been noted in some patients one day following their ophthalmic surgery.
Quarantine any affected lots and call Advanced Medical Optics Customer Care at 1-877-266-4543 for instructions on returning the product.
Additional details can be found at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm078714.htm - Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm109057.htm - Recall Notice:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm061978.htm
Updated
December 12, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
