CooperVision, Inc.: Device Recall

Recall #Z-2165-2025 · 06/16/2025

Class II: Risk

Recall Details

Recall Number: Z-2165-2025
Classification: Class II
Product Type: Device
Recalling Firm: CooperVision, Inc.
Status: Ongoing
Date Initiated: 06/16/2025
Location: Scottsville, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 397 units

Reason for Recall

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

Product Description

Biofinity XR Toric Contact Lens

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

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 02/27/2025

a limited number of lots were manufactured with an incorrect cylinder power.

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.