BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 5047872 · Received September 1, 2015

    Report

    Report Number
    3003288808-2015-06320
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    December 1, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND DURING THE DEVICE HISTORY RECORDS REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTANCE CRITERIA. HOSPITAL REQUESTED FOR TECHNICAL SERVICE FOR THE OPHTHALMIC LASER SYSTEM. DURING ON SITE VISIT THE SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION AND CALIBRATION OF Z-OFF SET. MACHINE WORKS CORRECT. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONTRIBUTING FACTORS COULD BE INCORRECT SETTING OF Z-OFFSET. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A CASE OF A MISMATCH OF THE PROGRAMMED CORNEAL FLAP THICKNESS WHEN COMPARED WITH THE POST FLAP GENERATED RESULTS. REPORTER INDICATED THERE WAS A THIRTY TO FORTY MICRON DIFFERENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE PHYSICIANS HAVE NOW PROGRAMMED A DIFFERENT THICKNESS WHICH THEY ARE SATISFIED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577842 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER OOE WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other