BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON

    MDR report key: 1881897 · Received October 19, 2010

    Report

    Report Number
    MW5017862
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LZS
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REVIEW OF THE OPERATIVE NOTES GENERATED FROM THE WAVELIGHT LASER, THE SURGEON OBSERVED THAT THE WRONG PLANNED TREATMENT WAS ENTERED INTO THE EXCIMER LASER LAPTOP COMPUTER FOR THE RIGHT EYE. THIS WAS CONFIRMED WITH THE CERTIFIED LASER TECHNICIAN BY REVIEWING THE DATA ON THE WAVELIGHT LAPTOP COMPUTER. IN REVIEW OF THE PROCEDURE, THE STANDARD OF CONFIRMING PT NAME, BIRTH DATE, EYE TO BE TREATED, AMOUNT OF LASER TREATMENT AS WELL AS LASIK FLAP PARAMETERS WERE PERFORMED APPROPRIATELY. +2.00+0.75 X 030 IT APPEARS, THAT THE LASER TECHNICIAN READ THE LASER TREATMENT OF THE SURGIVISION NOTE AND NOT FROM THE WAVELIGHT LAPTOP COMPUTER DISPLAY. IT APPEARS THAT FOR REASONS NOT YET UNDERSTOOD AN INCORRECT ENTRY WAS MADE INTO THE WAVELIGHT COMPUTER. ONE POSSIBILITY IS THAT THE DATA CHANGED WHEN SCROLLING DOWN THE PAGE. THIS RESULTED IN THE PT BEING TREATED AS THE FOLLOWING -1.25 +0.75 X 030 IN THE RIGHT EYE. OUR ALCON REP (B)(4) WAS CALLED AND INFORMED OF THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LASIK WAVEFORM LASER LZS ALCON LABORATORIES, INC. 200HR 1008-1-074

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other