# FDA recall Z-1197-2023

> **CooperVision, Inc.** · Class II · device recall initiated 2023-01-26.

## Product

Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)

## Reason for recall

Manufactured with misaligned axis resulting in  lenses with the incorrect power, users may experience poor visual acuity

## Distribution

US Nationwide distribution in the states of CA, OH, NC, PA.

## Key facts

- **Recall number:** Z-1197-2023
- **Recalling firm:** CooperVision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-26
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Henrietta, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2023

## Citation

> AI Analytics. FDA recall Z-1197-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1197-2023. Source: US FDA. Licensed CC0.

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