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U.S. Department of Health and Human Services

Safety

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Healon D Ophthalmic Viscosurgical Device

Audience: Ophthalmologic healthcare professionals

[Posted 12/11/2008] Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a Class I 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.

[January 02, 2009 - News Release - FDA]
[December 10, 2008 - Recall Notice - FDA]