BEUDAMED
    FDA Enforcement Class II Terminated

    Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 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-0990-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0990-2018
    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 HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 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

    AZ162110 AZ162120 AZ158510 AZ158520 AZ160420

    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

    5