BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX 4 EXCISER

    MDR report key: 1040349 · Received May 8, 2008

    Report

    Report Number
    MW5006791
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 24, 2006
    Report Date
    April 29, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH NO PREVIOUS OR FAMILY HISTORY OF GLAUCOMA HAD LASIK SURGERY IN 2005. SHORTLY THEREAFTER, THE RIGHT EYE DEVELOPED INCREASED INTRAOCULAR PRESSURE, WHICH WAS AT THE TIME ATTRIBUTED TO STEROID DROPS, WHICH REQUIRED EMERGENT SURGERY FOR GLAUCOMA WITH A TRABECULECTOMY. APPROXIMATELY 2 YEARS LATER, THE LEFT EYE (IN THE ABSENCE OF ANY CONCOMITANT MEDICATIONS) WAS FOUND TO HAVE INCREASED INTRAOCULAR PRESSURE, EVENTUALLY DIAGNOSED AS JUVENILE GLAUCOMA REQUIRING CHRONIC TREATMENT WITH EYE DROPS. LASIK HAS NOT BEEN KNOWN TO BE ASSOCIATED WITH GLAUCOMA, HOWEVER, IT WAS FELT THAT THIS SHOULD BE REPORTED. DOSE OR AMOUNT: SINGLE TREATMENT. DATES OF USE: 2005. DIAGNOSIS OR REASON FOR USE: CORRECTIVE VISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX 4 EXCISER NONE LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention| S