BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2606-2025 · Initiated August 22, 2025

    Recall

    Recall Number
    Z-2606-2025
    Event Number
    97515
    Firm
    CooperVision, Inc.
    FEI Number
    3005724763
    Product Code
    MVN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 22, 2025
    Posted
    September 19, 2025
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798

    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.

    Reason

    One lot manufactured with an invalid sterilization cycle.

    Action

    CooperVision contacted consignees via telephone call and letter on 08/27/2025. Consignees were instructed to examine inventory and quarantine affected lot numbers, cease further distribution of product, and notify customers/patients if further distributed. Consignees were also requested to complete and return the Correction Response Form and arrange for the return of affected units.

    Distribution

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

    Quantity

    4,140 units