BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT MEDICAL OPTICS

    MDR report key: 3118410 · Received May 13, 2013

    Report

    Report Number
    MW5030200
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    January 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE LENS WAS NOTED TO HAVE A SMALL DEFECT. IT WAS EXPLANTED AND REPLACED WITH AN IDENTICAL SIZE. ZCB00 23.0 DIOPTER, AMO SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211411 ABBOTT MEDICAL OPTICS ZCB00 23.0 DIOPTER IMPLANT HQL ABBOTT MEDICAL ZCB00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR