Recall Z-1291-2023 ยท LRO General Surgery Tray
Alcon Research, LLC
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 C
| Date | Mar 28, 2023 (initiated Mar 10, 2023) |
| Status | Open, Classified |
| Reason | Sterility; Steril surgical procedure packs contain incomplete seals. |
| Root cause | Employee error |
| Action | On March 10, 2023 Alcon issued a "Urgent: Voluntary Medical Device Removal" letter to affected consignees. In addition to notifying consignees about the recall product, they ask consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. See table on page 1 for affected Custom Pak lots. 2. Segregate any unused affected product from your inventory. 3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak. 4. Fill out the atta |
| Quantity | 1035 packs |
| Distribution | US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, 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 |