Recall Z-2110-2025 ยท LRO General Surgery Tray
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 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 various ophthal
| Date | Jul 10, 2025 (initiated Apr 28, 2025) |
| Status | Open, Classified |
| Reason | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. |
| Root cause | Under Investigation by firm |
| Action | On 05/01/2025, the firm sent via Overnight FedEx an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential for some trays within impacted lots to have damage in the Tyvek cover and compromising the sterility of the products. Customers are instructed: For Standalone Constellation kits- 1. Review inventory to locate, segregate and dispose of affected products 2. Call Alcon Customer Service to arrange for replacement products 3. Forward Post Recall Notice to all department within their organization and to facilities where the product may have been transfer t |
| Quantity | 15557 kits |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.