BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADAR6000 SYSTEM

    MDR report key: 856105 · Received May 24, 2007

    Report

    Report Number
    1061857-2007-00239
    Event Type
    Injury
    Date Received
    May 24, 2007
    Date of Event
    February 7, 2007
    Report Date
    April 24, 2007
    Manufacturer
    ALCON-ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A SURGEON REPORTS AN 'ATYPICAL' RESULT FOLLOWING A BILATERAL CUSTOM MYOPIA PROCEDURE. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT/INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. #1061857-2007-00239-RIGHT EYE. #1061857-2007-00240-LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADAR6000 SYSTEM OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON-ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other