FDA Device recall Z-2648-2024
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designe…
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designe… by Alcon Research, citing alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2648-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-15 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Product Name: Alcon Custom Pak Model/Catalog Number: Many 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 ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Reason
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Identifiers
| code_info | UDI-DIs: H5301ALCON1CPAK10 and H5302ALCON2CPAK20; Model Catalog numbers: 0210-71, 0515-65, 0613-84, 0775-69, 0835-60, 0…UDI-DIs: H5301ALCON1CPAK10 and H5302ALCON2CPAK20; Model Catalog numbers: 0210-71, 0515-65, 0613-84, 0775-69, 0835-60, 0852-75, 0884-77, 0900-28, 0972-31, 0995-82, 10027-12, 10066-19, 10068-19, 10214-20, 10214-21, 10275-17, 10308-11, 10342-17, 10477-21, 10568-13, 10604-09, 10731-20, 10772-35, 10782-30, 10825-17, 10931-13, 11066-08, 11220-25, 11367-23, 11413-14, 11414-07, 11426-24, 11497-12, 11732-16, 1192-67, 11952-15, 11958-08, 11994-15, 12005-09, 12262-06, 12329-16, 12346-08, 12359-14, 12364-13, 12376-03, 12382-10, 1239-67, 12417-11, 1249-62, 12498-07, 12518-11, 12532-05, 12698-09, 12699-12, 12918-12, 12918-13, 12942-18, 1303-69, 13204-19, 13214-21, 13335-11, 13569-13, 13578-17, 13592-15, 13614-16, 13644-08, 13657-10, 13732-19, 13870-09, 13894-16, 13944-12, 13955-09, 13982-13, 14129-09, 14174-15, 14226-12, 14302-07, 14362-18, 14363-14, 14385-05, 14387-05, 14429-09, 14442-16, 14477-12, 14611-15, 14688-15, 14719-09, 14853-13, 14864-11, 15061-09, 15133-16, 15190-16, 15194-09, 15220-10, 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2648-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.