BEUDAMED
    FDA Recall Terminated

    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses

    Recall: Z-0542-2014 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0542-2014
    Event Number
    66844
    Firm
    CooperVision Inc.
    FEI Number
    3005724763
    Product Code
    MVN
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    November 20, 2013
    Posted
    December 19, 2013
    Terminated
    July 22, 2015
    Address
    180 Thruway Park Dr W, Henrietta, NY, 14586-9798

    Description

    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses

    Reason

    Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

    Action

    CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to [email protected]. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.

    Quantity

    153 cartons