BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 823163 · Received February 28, 2007

    Report

    Report Number
    1061857-2007-00021
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    August 17, 2006
    Report Date
    August 17, 2006
    Manufacturer
    ALCON - ALCON TECHNOLOGY, CTR.
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL/INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTS A 'LOW ENERGY WARNING' ERROR MESSAGE AT THE END OF THE FIRST PROCEDURE FOLLOWING THE SUMMER HOLIDAY. THIS WAS A CONVENTIONAL, EPI-LASIK PROCEDURE. BASED ON THE INFO PROVIDED DURING THE COURSE OF THE INVESTIGATION, AT FOUR MOS POST-OP, THIS PT EXHIBITED A 2-LINE DECREASE IN BCVA IN THE RIGHT EYE. THE SURGEON INDICATED HE AND THE PT WAS HAPPY WITH THE OUTCOME; THE PT WORK AND FUNCTIONS WELL WITHOUT CORRECTIVE LENSES. THE SURGEON ALSO STATED THIS WAS AN EXPECTED RESULT BASED ON THE PT'S PRE-OP REFRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM DZS ALCON - ALCON TECHNOLOGY, CTR. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other