BEUDAMED
    FDA Enforcement Class II Terminated

    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.

    Recall: Z-0982-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0982-2018
    Event ID
    79377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alden Optical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 21, 2018
    Initiation Date
    November 3, 2017
    Classification Date
    March 13, 2018
    Termination Date
    June 19, 2018
    Address
    6 Lancaster Pkwy, Lancaster, NY, 14086-9713, United States

    Description

    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.

    Reason

    Contact lenses lack sterility assurance.

    Code Info

    AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920

    Distribution

    Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

    Quantity

    33