Recall Z-0939-2026 ยท LRO General Surgery Tray
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of vario
| Date | Dec 23, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | Ophthalmic procedure packs may have incomplete seals affecting sterility. |
| Root cause | Packaging |
| Action | On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. 2. Segregate and dispose of any unused affected product from your inventory. 3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 4. Respond to Alcon indicating your understanding of these instructions. 5. Please forward this notification to all departments within your organization |
| Quantity | 151 units |
| Distribution | US Nationwide distribution in the states of CA, ND, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.