BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOI

    MDR report key: 5322481 · Received December 23, 2015

    Report

    Report Number
    5322481
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    July 17, 2015
    Report Date
    December 1, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WATER LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848861 LOI UNIT, PHACOFRAGMENTATION HQC ABBOTT MEDICAL OPTICS LOI 1073641

    Patients

    Seq Age Sex Outcome Treatment
    1