BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 1448311 · Received August 21, 2009

    Report

    Report Number
    1061857-2009-00103
    Event Type
    Injury
    Date Received
    August 21, 2009
    Report Date
    July 22, 2009
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MAILED TO FDA ON: 08/21/2009.

    Description of Event or Problem · 1

    A LASER TECHNICIAN REPORTS THREE POSSIBLE CASES OF INDUCED ASTIGMATISM FOLLOWING REFRACTIVE SURGERY. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 LASER EXCIMER LASER SYSTEM LZS ALCON- ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other