BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON

    MDR report key: 829339 · Received March 14, 2007

    Report

    Report Number
    MW1042211
    Event Type
    Injury
    Date Received
    March 14, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 14, 2007
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1. PRE-OPERATIVE EQUIPMENT EVAL CORRECT PRIOR TO PROCEDURE. 2. ALCON PHACO EQUIPMENT FAILURE DURING INTRAOCULAR LENS PROCEDURE. 3. EQUIPMENT MALFUNCTION CALLED TO ALCON CO THROUGH 800 NUMBER. SUGGESTED NEED FOR REPLACEMENT FOOT PEDAL AND CABLE. 4. CO UNABLE TO PROVIDE TIMELY PRODUCT REPLACEMENT. 5. PROCEDURE ABORTED, CAPSULOTOMY PERFORMED. 6. SURGEON DECISION TO RECOVER PT, ATTACH EYE PATCH, TRANSPORT BY AMBULANCE TO ANOTHER SURGICAL FACILITY TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON INFINITI MACHINE HQC ALCON LABORATORIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability