BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOI

    MDR report key: 5322479 · Received December 23, 2015

    Report

    Report Number
    5322479
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 9, 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

    UNABLE TO SUCCESSFULLY VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846932 LOI UNIT, PHACOFRAGMENTATION HQC ABBOTT MEDICAL OPTICS LOI 1032988

    Patients

    Seq Age Sex Outcome Treatment
    1