Recall archive / FDA device enforcement
TECNIS Toric II OptiBlue IOL Models ZCW — FDA record Z-0735-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TECNIS Toric II OptiBlue IOL Models ZCW
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Quantity
- 36
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0735-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) 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 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Dec 12, 2023
- Center classification date
- Jan 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.