BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO LDV

    MDR report key: 3250706 · Received July 19, 2013

    Report

    Report Number
    3005643720-2013-00009
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LASIK FLAP: BUBBLE PATTERN IN CORNEA INDICATED A VERY SMALL AND DECENTERED FLAP; FLAP WAS LEFT UNOPENED AND PATIENT RESCHEDULED FOR LATER TREATMENT; NO IMPAIRMENT EXPECTED. NO INDICATION FOR MALFUNCTION; OPERATOR WAS TRAINED BUT INFREQUENT USER; MOST LIKELY CAUSE IS PSEUDO-VACUUM (FLOATING CONJUNCTIVA BLOCKING THE VACUUM DUCT) LEADING TO IMPERFECT APPLANATION; CUT OCCURRED IN BOWMAN'S MEMBRANE/EPITHELIUM, LEADING TO A TRANSIENT BUBBLE PATTERN RATHER THAN A FLAP; INSTRUCTION TO PREVENT THIS ISSUE ARE GIVEN IN THE USER MANUAL AND USER TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338179 FEMTO LDV FEMTO LDV GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING Z4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other