BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 5210919 · Received November 9, 2015

    Report

    Report Number
    3003288808-2015-06752
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 30, 2015
    Report Date
    January 18, 2016
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLOCK START DATE ON THE MDR WAS ORIGINALLY REPORTED AS (B)(6) 2015, THE CORRECT DATE SHOULD HAVE BEEN (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO MATERIAL WAS RETURNED TO THE INVESTIGATION SITE FOR EVALUATION. THE PROCEDURE MANUAL GIVES OPAQUE BUBBLE LAYER (OBL) AS A POSSIBLE COMPLICATION. THE SYSTEM HISTORY SHOWED THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR ((B)(6) 2015) THE DATE OF TREATMENT. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON MANUFACTURER'S ACCEPTANCE CRITERIA. THE LOG FILE REVIEW SHOWED THAT 44 TREATMENTS WERE PERFORMED BETWEEN THE COMPLETE DEVICE CHECK BY A COMPANY REPRESENTATIVE ON (B)(6) 2015 AND THE SUSPECT TREATMENT ON (B)(6) 2015. NO SYSTEMATIC NEGATIVE INFLUENCE ON THE TREATMENTS WAS IDENTIFIED, WHICH CORRESPONDS WITH THE PASSED TESTS AT THE FIELD VISIT BEFORE THE DAY OF TREATMENT. LOG FILE REVIEW FOR THE RESPECTIVE PROCEDURE SHOWED NO SYSTEM MESSAGE DURING THE TREATMENT. ENERGY SETTINGS, SPOT/LINE SEPARATION AND SIMILAR SET BY THE SURGEON WERE IN THE RECOMMENDED RANGE. AT THE VISIT ON SITE AFTER THE DAY OF TREATMENT A COMPANY REPRESENTATIVE IDENTIFIED THE FLAP WAS APPROXIMATELY 10 MICRONS THINNER THAN EXPECTED (AT THE BORDERLINE OF THE TOLERANCE OF 10 MICRONS). THE COMPANY REPRESENTATIVE FOUND THE IRIS APERTURE WAS PARTLY CLOSED, INSTEAD OF BEING COMPLETELY OPEN. POTENTIAL CONSEQUENCES: MORE ROUGH CUTTING SURFACE. THIS MAY LEAD TO A THINNER FLAP, HIGHER LIKELIHOOD OF VERTICAL GLASS BREAKTHROUGH (VGB) AND OBL, WHICH IS KNOWN TO CAUSE ISSUES AT OPENING THE FLAP. THE COMPANY REPRESENTATIVE PERFORMED A FULL ALIGNMENT AND MADE SURE THE IRIS APERTURE WAS COMPLETELY OPEN. THE TREATMENT REPORT WAS REVIEWED. ACCORDING TO THE IMAGE IN THE TREATMENT REPORT, A VGB HAD OCCURRED. VGB IS KNOWN TO APPEAR IN THIN CUTS MORE OFTEN WHEN COMPARED TO THICK FLAPS. ACCORDING TO THE TREATMENT REPORT, THE DESIRED FLAP THICKNESS WAS 120 M. THE VISUAL IMPRESSION OF THE FLAP CREATED WAS A RATHER THIN FLAP. AN ADDITIONAL REASON FOR THE APPEARANCE OF THE VGB IS THE CANAL HAS BEEN SET SLIGHTLY TOO SHORT BY THE USER. THE ACCUMULATED GAS LIKELY CAUSED THE LARGE OBL, EXPANSION OF THE STROMA AND THEREFORE A THINNER CUT. THE THIN CUTTING PLANE AND HIGH GAS PRESSURE LEADS TO VERTICAL GAS BREAK THROUGH. THE MOST LIKELY ROOT CAUSE WAS A TOO SHORT CANAL SET BY THE USER. A CONTRIBUTING FACTOR WAS CONSIDERED THE PARTLY CLOSED IRIS APERTURE TRACED BACK TO IMPROPER ALIGNMENT BY COMPANY REPRESENTATIVE.

    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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS PROVIDED BY THE SURGEON WHO REPORTED THAT THE SYSTEM FAILED WHILE DOING THE FLAP TO THE LEFT EYE. IT WAS UNABLE TO RAISE THE FLAP. PER SURGEON, THE DEVICE CAUSE OR CONTRIBUTE TO THE EVENT DUE TO FLAP WAS TOO THIN AND UNEVEN. THE PATIENT REPORTED HALOS AND GLARE IMMEDIATELY AFTER THE SURGERY. TREATMENT WITH MEDICATION WAS PROVIDED.

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INCOMPLETE FLAP ON A PATIENT'S EYE DURING A REFRACTIVE PROCEDURE. SURGEON NOTED THAT A LOT OF OPAQUE BUBBLE LAYER HAD FORMED. FLAP WAS PARTLY LIFTED FROM THE SUPERIOR HALF. INFERIOR HALF WAS LEFT UNTOUCHED. PROCEDURE WAS CANCELLED. AT FOLLOW UP VISIT, IT WAS DETERMINED THAT PATIENT WILL HAVE SURGERY WHEN TOPOGRAPHY IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743081 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other