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FDA MedWatch

Healon D Ophthalmic Viscosurgical Device: recall due to syringes with endotoxin levels above the required limit

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.

Read the MedWatch 2008 safety summary, including a link to the recall notice, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Healon

 

 

 

 

 

 
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