Recall Z-1643-2009 ยท NGY Cannula, Trocar, Ophthalmic
Alcon Laboratories, Inc
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
| Date | May 26, 2009 (initiated Apr 29, 2009) |
| Status | Terminated |
| Reason | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
| Root cause | Process control |
| Action | Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance |
| Quantity | 3,523 surgical paks. |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911808 | GEMINI OPHTHALMIC SURGERY SYSTEM Alcon Laboratories, Jun 25, 1991 |