Recall Z-0343-2009 ยท LZP Aid, Surgical, Viscoelastic
Advanced Medical Optics, Inc.
AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
| Date | Dec 10, 2008 (initiated Oct 29, 2008) |
| Status | Terminated |
| Reason | Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery. |
| Root cause | Process design |
| Action | On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form. The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions: (1) STOP using |
| Quantity | 1450 |
| Distribution | Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.