TECNIS Symfony — Class II medical device recall Z-2288-2023
Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2023-08-09. Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
| Recall number | Z-2288-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc., Irvine, CA, United States |
| Recall initiated | 2023-07-06 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Countries outside the US | CN, IN, KR |
| Quantity | 42 |
| UPC / GTIN / UDI-DI | 05050474579163 |
| Serial numbers | 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244 and 17 more |
| Model numbers | ZXR00 |
Product
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Reason for recall
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
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-2288-2023. 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.