BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT MEDICAL OPTICS

    MDR report key: 3167587 · Received June 10, 2013

    Report

    Report Number
    MW5030509
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    January 22, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON IMPLANTED AN ABBOTT MEDICAL OPTICS OPHTHALMIC LENS ON (B)(6) 2012. AFTER EXPRESSION OF DISSATISFACTION FROM THE PT REGARDING THE LENS (EXPECTED RESULTS WERE NEVER REACHED) AND 11 MONTHS OF FOLLOW UP CARE FORM THE PHYSICIAN, THE PHYSICIAN EXPLANTED THE LENS ON (B)(6) 2013 AND IMPLANTED AND DIFFERENT LENS FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261384 ABBOTT MEDICAL OPTICS INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR