BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE REVITALENS

    MDR report key: 4153430 · Received October 8, 2014

    Report

    Report Number
    3004537773-2014-00007
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    PMA / PMN Number
    K093254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A CONSUMER THAT A BOTTLE OF COMPLETE REVITALENS WAS LEAKING FROM THE TOP ALTHOUGH IT WAS SEALED. THE UNIT WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. NO CONSUMER INVOLVEMENT SINCE THE BOTTLE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630875 COMPLETE REVITALENS SOLUTIONS LPN ABBOTT MEDICAL OPTICS 09608X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1