BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2231203 · Received August 25, 2011

    Report

    Report Number
    3003288808-2011-00257
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 27, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TM (TERRITORY MGR - FIELD SERVICE ENGINEER) WAS AT THE SITE TO VERIFY THE SIDE CUT. FULL SYSTEM VERIFICATION WAS PERFORMED. NO PROBLEM FOUND WITH SYSTEM. SYSTEM MEETS PRODUCT STANDARDS. THE SURGEON STATED THAT THE ISSUES WERE DUE TO THE USE OF A NEW SYSTEM, WITH NEW TECHNOLOGY. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS USER HANDLING. (B)(4).

    Description of Event or Problem · 1

    A LASER TECH REPORTS A PT WITH A FLAP ISSUE; THE FLAP DID NOT LIFT CLEANLY AT THE SIDE CUT, RESULTING IN A SMALL TEAR WHEN THE FLAP WAS LIFTED. THE SURGEON STATED THERE ARE NO CONCERNS FOR THIS PT. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MFR REPORT NUMBER 3003288808-2011-00259. DURING A F/U CALL, THE SURGEON STATED THE PT IS DOING WELL AND HE IS SATISFIED THAT THE ISSUES WERE DUE TO THE USE OF A NEW SYSTEM, WITH NEW TECHNOLOGY. NO FURTHER INFO IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other