BEUDAMED
    FDA Enforcement Class II Terminated

    Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE 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). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

    Recall: Z-0985-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0985-2018
    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 HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE 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). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

    Reason

    Contact lenses lack sterility assurance.

    Code Info

    AZ160210 AZ151320

    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

    2