BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON LABORATORIES

    MDR report key: 493836 · Received October 29, 2003

    Report

    Report Number
    MW1030003
    Event Type
    Injury
    Date Received
    October 29, 2003
    Date of Event
    October 28, 2003
    Report Date
    October 29, 2003
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PHACOEMULSIFICATION CATARACT SURGERY, DURING THE FIRST PASS, THERE WAS SOME OVERHEATING OF THE PHACO TIP AND CORNEAL BURN WAS SUSTAINED. THE PHACO HANDPIECE WAS THEN EXCHANGED FOR A NEW HANDPIECE AND RETESTED AND FUNCTIONED IN GOOD CONDITION. THE PHACOEMULSIFICATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES CATARACT UNIT PHACOEMULSIFICATION HQC ALCON LABORATORIES STTL1 -UNIT- NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention