Product Name: Alcon Custom Pak Model/Catalog Number: Many Software… — Class II medical device recall Z-2648-2024
Ongoing recall by Alcon Research LLC, reported 2024-08-28, distributed nationwide. Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Side
| Recall number | Z-2648-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2024-07-15 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, HU, IE, IN, IT, JP, KR, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RU, SE, SG, TH, TR, TW, UA, UY, ZA |
| Quantity | 384,851 units |
| Lot numbers | 165DRJ, 165FKV, 165Y8W, 165YA5, 165YN0, 165YPJ, 166798, 1667A5, 1668VE, 166C7D, 166EDF, 166EDM, 166H41, 166MY2, 166N03, 166N0Y, 166PM7, 166PMR, 166PMU, 166PN0, 166PNM, 166PNU, 166PNW, 166PP1, 166PPA, 166PPC, 166V6M, 166V6W, 166V7J, 166V8P, 166VR2, 166YH3, 166YHM, 166YKD, 16716R, 16719J, 16734T, 1673NX, 1673P9, 1673PD and 460 more |
| Model 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 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2648-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.