Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC… — Class II medical device recall Z-0464-2019
Terminated recall by Johnson & Johnson Surgical Vision Inc, reported 2018-11-21, distributed nationwide. Expired intraocular lenses were distributed.
| Recall number | Z-0464-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision Inc, Santa Ana, CA, United States |
| Recall initiated | 2018-06-21 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 17 iol |
| UPC / GTIN / UDI-DI | 05050474558076, 05050474558090, 05050474558106, 05050474558113, 05050474558120, 05050474558137, 05050474558144, 05050474558151, 05050474558175, 05050474558410, 05050474558434, 05050474558441, 05050474558458, 05050474558465 |
| Model numbers | 10.5D, 11.5D, 12.0D, 12.5D, 13.0D, 13.5D, 14.0D, 14.5D, 15.5D, 2173131504, 2212331502, 2354451505, 2577541505, 27.5D, 28.5D, 29.0D, 29.5D, 30.0D, 3004621502, 3224481503, 3242641504, 3488131502, 3496431503, 3526291503, 3595511502 and 7 more |
| Expiration dates | 2017-10-09, 2018-02-03, 2018-02-10, 2018-02-13, 2018-02-14, 2018-02-17, 2018-02-26, 2018-03-10, 2018-03-11, 2018-03-31, 2018-04-02, 2018-04-13, 2018-05-07, 2018-05-11 |
Product
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
Reason for recall
Expired intraocular lenses were distributed.
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-0464-2019. 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.