BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 704929 · Received March 27, 2006

    Report

    Report Number
    1061857-2006-00149
    Event Type
    Injury
    Date Received
    March 27, 2006
    Report Date
    September 27, 2005
    Manufacturer
    ALCON-ORLANDO TECHNOLOGY CTR
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING LASIK SURGERY, THIS PT EXHIBITED A DECREASE OF 2 LINES BCVA IN THE LEFT EYE AT THE 1-WEEK POST-OPERATIVE VISIT. THE PT WAS ALSO OVER CORRECTED IN THIS EYE BY 2:00 DIOPTERS. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other