Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number:… — Class II medical device recall Z-2647-2024
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-2647-2024 |
|---|---|
| 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 | 8,701 units |
| UPC / GTIN / UDI-DI | 00380658300777 |
| Lot numbers | 16A6HT, 16A6HU, 16A6HV, 16FE93, 16FX1Y, 16FX20, 16HE6Y, 16HE70, 16HYEN, 16HYEP |
| Model numbers | 8065830077 |
Product
Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. 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-2647-2024. 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.