Phaco Standalone Tips — Class II medical device recall Z-2410-2023
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-2410-2023 |
|---|---|
| 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 | 444,372 units |
| UPC / GTIN / UDI-DI | 00380657403028, 00380657403042, 00380657408061, 00380657408375, 00380657502615, 00380657502639, 00380657502646, 00380657508525, 00380657508532, 00380657511761, 00380657511778, 00380657511785, 00380657520657, 00380657520664, 00380657900206, 00380657900220, 00380657900237 |
| Lot numbers | 146WR7, 146X46, 146X4J, 14C5KL, 14C5L1, 14C5UK, 14C5UL, 14D015, 14D0HP, 14D0J0, 14DNN3, 14DYMF, 14H9TN, 14HA12, 14HA15, 14HA16, 14HE56, 14LH5P, 14LH5T, 14LH5U, 14LH5W, 14LH5X, 14LHD7, 14LHKX, 14LHL0, 14LHL1, 14LHL3, 14LHL4, 14MV1X, 14MV1Y, 14MV20, 14N03C, 14N03D, 14N03E, 14N03H, 14N03U, 14N03V, 14N0A2, 14N0A3, 14N0A4 and 306 more |
| Model numbers | 30KTS, 30RTS, 8065740806, 8065740837, 8065750261, 8065750263, 8065750264, 8065750852, 8065750853, 8065751176, 8065751177, 8065751178, 8065752065, 8065752066, 8065790020, 8065790022, 8065790023 |
Product
Phaco Standalone Tips
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-2410-2023. 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.