TECNIS Toric II OptiBlue IOL Models ZCW — Class II medical device recall Z-0735-2024
Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2024-01-24. Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet pr
| Recall number | Z-0735-2024 |
|---|---|
| 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 | 2023-12-12 |
| Classified | 2024-01-16 |
| Reported by FDA | 2024-01-24 |
| Countries outside the US | JP |
| Quantity | 36 |
| Reason classes | specification failure |
| Serial numbers | 3473902107, 3473912107, 3473922107, 3473932107, 3473942107, 3473952107, 3473962107, 3473972107, 3474002107, 3474012107, 3474022107, 3474072107, 3474082107, 3474092107, 3474102107, 3474112107, 3474122107, 3474132107, 3474152107, 3474162107, 3474172107, 3474182107, 3474192107, 3474202107, 3474222107 and 11 more |
| Model numbers | ZCW375 |
Product
TECNIS Toric II OptiBlue IOL Models ZCW
Reason for recall
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis 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-0735-2024. 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.