Alcon Custom Pak — Class II medical device recall Z-2411-2023
Ongoing recall by Alcon Research, LTD., reported 2023-08-23, distributed nationwide. Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening wi
| Recall number | Z-2411-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Sinking Spring, PA, United States |
| Recall initiated | 2023-06-28 |
| Classified | 2023-08-16 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, AW, BB, BD, BE, BG, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LU, LV, MA, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 1,682,351 units |
| UPC / GTIN / UDI-DI | 00380651636958, 00380651648500, 00380651648579, 00380651649217, 00380651649880, 00380651652736, 00380651654303, 00380651654440, 00380651654532, 00380651654587, 00380651654617, 00380651654624, 00380651654730, 00380651656826, 00380651656871, 00380651657540, 00380651657571, 00380651657588, 00380651657601, 00380651657663, 00380651657724, 00380651657755, 00380651657762, 00380651657830, 00380651657878 and 475 more |
| Lot numbers | 14P98V, 14UJ5F, 14VJ3D, 14VLWF, 14WF92, 14WWRF, 14WYX8, 14WYXU, 14X0AC, 14X0HK, 14X10Y, 14X125, 14X1FC, 14X253, 14X2MM, 14X44N, 14X4PW, 14X508, 14X5K8, 14X68K, 14X6EP, 14X9T5, 14X9TN, 14X9U8, 14XA9M, 14XA9N, 14XA9X, 14XDNX, 14XE1T, 14XE20, 14XE24, 14XE2C, 14XE2L, 14XE2P, 14XEUW, 14XEV2, 14XEV4, 14XEV5, 14XEVH, 14XEVM and 460 more |
| Model numbers | 0007-67, 0091-69, 0210-70, 0302-82, 0349-78, 0365-75, 0437-38, 0680-74, 0693-66, 0781-63, 0815-68, 0880-41, 0888-69, 0900-28, 0938-60, 0956-69, 0995-82, 10008-16, 10014-63, 10014-64, 10019-15, 10027-12, 10066-19, 10101-16, 10101-17 and 475 more |
Product
Alcon Custom Pak
Reason for recall
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
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-2411-2023. 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.