CooperVision, Inc.: Device Recall

Recall #Z-2607-2025 · 08/22/2025

Class II: Risk

Recall Details

Recall Number: Z-2607-2025
Classification: Class II
Product Type: Device
Recalling Firm: CooperVision, Inc.
Status: Ongoing
Date Initiated: 08/22/2025
Location: West Henrietta, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 180 units

Reason for Recall

One lot manufactured with an invalid sterilization cycle.

Product Description

Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.

Distribution Pattern

US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.

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 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.
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.