BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.3 MM TRANSFORMER I/A IRRIGATION AND ASPIRATION TOOL

    MDR report key: 12016627 · Received June 16, 2021

    Report

    Report Number
    MW5101945
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, THE IRRIGATION AND ASPIRATION TOOL WAS NOT ABEL TO ASPIRATE THE CORTEX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902797 0.3 MM TRANSFORMER I/A IRRIGATION AND ASPIRATION TOOL UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC '806575288S' 13TT8P

    Patients

    Seq Age Sex Outcome Treatment
    1