CooperVision, Inc.: Device Recall

Recall #Z-2606-2025 · 08/22/2025

Class II: Risk

Recall Details

Recall Number
Z-2606-2025
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
4,140 units

Reason for Recall

One lot manufactured with an invalid sterilization cycle.

Product Description

MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 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.

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.