BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 3252221 · Received July 25, 2013

    Report

    Report Number
    3003288808-2013-00436
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING LASIK FLAP CREATION, SUCTION WAS LOST AFTER BEGINNING THE CANAL. THE PT INTERFACE WAS EXCHANGED FOR A NEW ONE AND THE SURGEON DECIDED TO BEGIN AGAIN WITH NO ALTERATION TO THE SETTINGS. THE FLAP WAS CREATED SUCCESSFULLY WITH VERY SLIGHT OPAQUE BUBBLE LAYER AND THE TREATMENT WENT IT WELL. THERE WAS NO HARM TO THE PT. THE SURGEON INDICATED THAT HE HAD TIGHTENED HIS GRIP ON THE SUCTION RING, WHICH MAY HAVE CAUSED THE LOSS OF VACUUM DUE TO THE ANGLE OF THE RING ON THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347547 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK