CooperVision, Inc.: Device Recall

Recall #Z-3310-2024 · 08/29/2024

Class II: Risk

Recall Details

Recall Number: Z-3310-2024
Classification: Class II
Product Type: Device
Recalling Firm: CooperVision, Inc.
Status: Ongoing
Date Initiated: 08/29/2024
Location: West Henrietta, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 607 lenses

Reason for Recall

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

Product Description

BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Other Recalls by CooperVision, Inc.

Class II: Risk 08/22/2025

One lot manufactured with an invalid sterilization cycle.
Class II: Risk 08/22/2025

One lot manufactured with an invalid sterilization cycle.
Class II: Risk 08/22/2025

One lot manufactured with an invalid sterilization cycle.
Class II: Risk 06/16/2025

Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Class II: Risk 06/16/2025

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

View all recalls by CooperVision, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.