BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO LDV

    MDR report key: 3093954 · Received April 26, 2013

    Report

    Report Number
    3004858034-2013-00011
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    GEX
    PMA / PMN Number
    K053511
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR APPLIED TOO MUCH VISIOL ONTO THE CORNEA; EXCESS VISCOELASTIC PLACED BETWEEN THE EYE AND THE APPLANATION SURFACE LED TO A FLAP OF INTERIOR AND IRREGULAR THICKNESS.

    Description of Event or Problem · 1

    CORNEAL FLAP COULD NOT BE ENTIRELY OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181787 FEMTO LDV FEMTO LDV GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING CLASSIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other