BEUDAMED
    FDA Enforcement Class III Terminated

    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

    Recall: Z-1517-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1517-2018
    Event ID
    79755
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperVision Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    February 21, 2018
    Classification Date
    April 25, 2018
    Termination Date
    October 2, 2019
    Address
    180 Thruway Park Dr, N/A, W Henrietta, NY, 14586-9798, United States

    Description

    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

    Reason

    The secondary packaging is labeled with an incorrect expiration date.

    Code Info

    Lot 14364100237018, Exp. Date 9/30/2020 (foil); 9/30/2022 (carton)

    Distribution

    US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.

    Quantity

    328 packs/3280 lenses