# FDA recall Z-0691-2018

> **CooperVision Inc.** · Class III · device recall initiated 2017-09-01.

## Product

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK      Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.

## Reason for recall

The firm identified a labeling error affecting Made-To-Order  (MTO) Biofinity XR Toric blister labels. The primary blister reads  Biofinity Multifocal Toric  in error, and should read  Biofinity XR Toric.  The outer carton correctly reads  Biofinity XR Toric.

## Distribution

USA Distribution

## Key facts

- **Recall number:** Z-0691-2018
- **Recalling firm:** CooperVision Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-01
- **Report date:** 2018-03-07
- **Termination date:** 2018-07-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0691-2018

## Citation

> AI Analytics. FDA recall Z-0691-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0691-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*