Recall Z-0260-2024 ยท LRO General Surgery Tray
Alcon Research, LLC
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
| Date | Nov 7, 2023 (initiated Sep 7, 2023) |
| Status | Open, Classified |
| Reason | Custom surgical procedure packs contain latex gloves but are labeled as "latex free". |
| Root cause | Nonconforming Material/Component |
| Action | On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks. |
| Quantity | 120 packs |
| Distribution | US: VA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |