BEUDAMED
    FDA Enforcement Class III Terminated

    Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.

    Recall: Z-2982-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2982-2018
    Event ID
    80800
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alden Optical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 12, 2018
    Initiation Date
    July 3, 2018
    Classification Date
    September 6, 2018
    Termination Date
    February 28, 2020
    Address
    6 Lancaster Pkwy, N/A, Lancaster, NY, 14086-9713, United States

    Description

    Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.

    Reason

    Vials labeled for the prescriptions contained incorrect lenses

    Code Info

    B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008

    Distribution

    US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.

    Quantity

    4 vials