BEUDAMED
    FDA Enforcement Class II Ongoing

    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

    Recall: Z-1282-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1282-2023
    Event ID
    91793
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperVision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    March 23, 2023
    Address
    180 Thruway Park Dr, N/A, West Henrietta, NY, 14586-9798, United States

    Description

    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

    Reason

    The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

    Code Info

    Lot Number W0124677

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.

    Quantity

    3150