BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT MEDICAL OPTICS INTUITIV PHACOEMULSIFIER

    MDR report key: 5688294 · Received May 24, 2016

    Report

    Report Number
    MW5062527
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    February 18, 2016
    Report Date
    May 24, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ABBOTT MEDICAL OPTICS INTUITIV PHACO MACHINE CEASED WORKING AND MADE A LOUD, UNSTOPPABLE NOISE DURING CATARACT SURGERY. MACHINE FAILED TO WORK ON FIRST REBOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329749 ABBOTT MEDICAL OPTICS INTUITIV PHACOEMULSIFIER ABBOTT MEDICAL OPTICS INTUITIV PHACOEMULSIFIER HQC ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention