# FDA recall Z-0735-2024

> **Johnson & Johnson Surgical Vision, Inc.** · Class II · device recall initiated 2023-12-12.

## 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.

## Distribution

International distribution to the country of Japan.

## Key facts

- **Recall number:** Z-0735-2024
- **Recalling firm:** Johnson & Johnson Surgical Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-12
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2024

## Citation

> AI Analytics. FDA recall Z-0735-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0735-2024. Source: US FDA. Licensed CC0.

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