BEUDAMED
    FDA Enforcement Class II Terminated

    Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

    Recall: Z-0987-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0987-2018
    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

    Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

    Reason

    Contact lenses lack sterility assurance.

    Code Info

    AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620 AZ156210 AZ156220 AZ151510 AZ155210 AZ138410 AZ138420 AZ154810 AZ154620 AZ162310 AZ162320 AZ159810 AZ159820 AZ145220 AZ151120

    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

    56