BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2231152 · Received August 26, 2011

    Report

    Report Number
    3003288808-2011-00260
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A LASER TECH REPORTED THE EYE APPEARED TO MOVE UPWARD, WHILE THE APPLANATION CONE OF THE PT INTERFACE DID NOT, RESULTING IN AN IRREGULAR FLAP. THIS OCCURRED DURING THE FINAL PART OF THE FLAP CREATION FOR THE RIGHT EYE OF A PT. THE PT REQUESTED THE SURGEON TO PROCEED WITH THE SURGERY ON THE LEFT EYE. THIS PROCEDURE WAS COMPLETED WITH NO ISSUES. THE SURGEON THEN SENT THE PT HOME TO ALLOW THE FLAP ON THE RIGHT EYE TO HEAL BEFORE COMPLETING THE SURGERY FOR THIS EYE. DURING A FOLLOW-UP CALL, THE SURGEON STATED THE FLAP OF THE RIGHT EYE IS HEALING WELL AND PLANS TO COMPLETE THE PROCEDURE IN SEPTEMBER.

    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 Required Intervention