BEUDAMED
    FDA Recall Terminated

    CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

    Recall: Z-2147-2021 · Initiated May 19, 2021

    Recall

    Recall Number
    Z-2147-2021
    Event Number
    88096
    Firm
    CooperVision Inc.
    FEI Number
    3005724763
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 19, 2021
    Terminated
    March 13, 2023
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798

    Description

    CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

    Reason

    Misaligned placement of an axis mark can cause the patient to experience blurred vision

    Action

    Coopervision issued Urgent Medical Device Correction letter on 5/19/21 to wholesale/distributor and Eye Care Practitioner level. The independent accounts via overnight FedEx (receipt tracking). Distributors and corporate accounts via email, with a read receipt. Letter states reason for recall, health risk and action to take: Examine your inventory for the affected lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of clariti 1 day toric lenses. " Dispose of the product and, within the next five (5) business days, please complete the attached Correction Response Form and fax it to 866-484-1048 or scan and email to: [email protected]. Your account will be credited once the form is received. If you have any further questions, please feel free to contact CooperVision Customer Service at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.

    Quantity

    1260 lenses