BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX STAR S4 LASER

    MDR report key: 1712756 · Received May 29, 2010

    Report

    Report Number
    MW5016211
    Event Type
    Injury
    Date Received
    May 29, 2010
    Date of Event
    March 11, 2009
    Report Date
    May 29, 2010
    Manufacturer
    VISX STAR S4 LASER
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LASIK-CAUSED SEVERE DRY EYE, NIGHT VISION PROBLEMS-HALOS, STARBURSTS, GHOSTING. INTERLASE CORP, VISC STAR S4 EXCIMER LASER SYSTEM, CUSTOM VUE. LASIK DONE ON (B) (6) 2009. SEVERAL FOLLOW UPS AFTER PROCEDURE DATES ARE IN MY MEDICAL RECORDS. LASIK DOCTOR COULD NOT HELP ME AND WOULD NOT HELP ME. HAD TO GO TO SEVERAL OTHER DOCTORS FOR ANY TYPE OF HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX STAR S4 LASER VISX STAR S4 LASER LZS VISX STAR S4 LASER

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention