Recall Z-1328-2021 ยท LRO General Surgery Tray
Alcon Research, LLC
Alcon Custom Ophthalmic Surgical Procedure Packs
| Date | Apr 1, 2021 (initiated Feb 2, 2021) |
| Status | Terminated |
| Reason | Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages. |
| Root cause | Nonconforming Material/Component |
| Action | On February 2, 2021 Alcon issued an :Urgent: Voluntary Medical Device Removal letter via FedEx mail to all affected consignees. On February 12, 2021 and April 9, 2021, Alcon expanded their recall to additional lots and consignees. On June 14, 2021, Alcon expanded their recall and issued an URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION (FIELD ACTION EXPANSION) letter to affected consignee via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Forward this notification to all departments or organizations using your Cu |
| Quantity | 249,853 Custom Packs |
| Distribution | Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |