BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO LDV SYSTEM

    MDR report key: 3250705 · Received July 19, 2013

    Report

    Report Number
    3005643720-2013-00008
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SIE AG; SURGICAL INSTRUMENT ENGINEER
    Product Code
    GEX
    PMA / PMN Number
    K053511
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LASIK FLAPS: OPERATOR COMPLAINED THROUGH DISTRIBUTOR ABOUT EXCESSIVE TISSUE BRIDGES AND DIFFICULT-TO-OPEN BORDER CUTS; IN ONE CASE, A FLAP COULD NOT BE OPENED; OPERATOR REFUSED TO GIVE FURTHER DETAILS ON AFFECTED PATIENT; ADJUSTMENT OF PROCESS PARAMETERS WAS SUGGESTED TO OPERATOR, NO FURTHER REPORTS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338213 FEMTO LDV SYSTEM FEMTO LDV CRYSTALLINE GEX SIE AG; SURGICAL INSTRUMENT ENGINEER CRYSTALLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other