BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 1751127 · Received July 2, 2010

    Report

    Report Number
    3006695864-2010-00074
    Event Type
    Injury
    Date Received
    July 2, 2010
    Report Date
    June 28, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): REPORTER, CLINIC AND SPECIFIC EQUIPMENT WAS NOT PROVIDED IN THE REPORT AND IS NOT KNOWN. UNABLE TO FOLLOW-UP.

    Description of Event or Problem · 1

    A PT REPORT WAS RECEIVED FROM FDA'S MEDWATCH PROGRAM REPORTING THE FOLLOWING: LASIK CAUSED DRY EYE, NIGHT VISION PROBLEMS, HALOS, STARBURSTS, GHOSTING. INTRALASE CORP, VISC STAR S4 EXCIMER LASER SYSTEM, CUSTOMVUE, LASIK DONE IN 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 EXCIMER LASER LZS AMO MANUFACTURING USA, LLC STAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other