BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 11615496 · Received April 5, 2021

    Report

    Report Number
    3003288808-2021-00174
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    December 16, 2020
    Report Date
    June 15, 2021
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K141476
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATING THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4)

    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 MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN INCOMPLETE SIDE DURING A FLAP CREATION CASE. SUCTION LOSS WAS REPORTED TO HAVE OCCURRED BEFORE THE LASER FIRED. ADDITIONAL INFORMATION IS NOT AVAILABLE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT WITH SUCTION LOSS AND INCOMPLETE SIDE ON (B)(6) 2020 AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512002 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 WAVELIGHT FS200 EASYPACK PATIENT INTERFACE