BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT MEDICAL OPTICS

    MDR report key: 3118106 · Received May 13, 2013

    Report

    Report Number
    MW5030188
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    January 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    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

    THERE WAS IN IMPERFECTION IN THE ZCB00 +22.0 LENS THAT WAS INSERTED. THE MD HAD TO REMOVE IT AND REPLACE IT WITH ANOTHER ZCB00 +22.0 LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210301 ABBOTT MEDICAL OPTICS TECNIS ZCB00 HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR