BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 17780803 · Received September 20, 2023

    Report

    Report Number
    3003288808-2023-00259
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 4, 2023
    Report Date
    December 18, 2023
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    UDI-DI
    00380659909412
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN A.2., A.3., B.5., H.10., AND H.11. THE INITIAL DECISION TO REPORT WAS INCORRECT RESULTING IN THE INITIAL REPORT BEING SUBMITTED IN ERROR. THIS FILE IS DUPLICATE FOR MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL THE THICKNESS OF THE FLAP WAS INACCURATE WHERE CORNEAL EPITHELIAL OF THE EYE WAS HIT DURING THE OPERATION, AND THERE WAS A FISH SCALE SHAPED ABNORMALITY, DURING THE FLAP LIFTING PROCESS, THE LOWER FLAP WAS TORN IN THE LEFT EYE DURING LASIK SURGERY. THE PATIENTS SYMPTOMS WAS IMPROVING. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT HY Y'S LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Description of Event or Problem · 0

    NEW INFORMATION WAS RECEIVED. THIS FILE WAS FOUND DUPLICATE OF MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4). HENCE, NOT QUALIFIED FOR THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71001 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA 143127 00380659909412

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male WAVELIGHT FS200 EASYPACK PATIENT INTERFACE