BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 11693057 · Received April 20, 2021

    Report

    Report Number
    3003288808-2021-00201
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    April 2, 2021
    Report Date
    August 25, 2021
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K141476
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. DURING A TECHNICAL ONSITE VISIT, THE FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM VERIFICATION AND DID NOT CONFIRM ANY MALFUNCTION. SYSTEM MEETS SPECIFICATIONS AS PER SERVICE INSTALLATION RECORD (SIR). THE REVIEW OF LOGFILE FOR THE DAY OF TREATMENT SHOWED ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. DURING START-UP OF THE SYSTEM, THE VACUUM, THE ENERGY AND THE ABLATION TESTS WERE PERFORMED WITHOUT ANY ISSUE. THE ENERGY WAS STABLE DURING THE WHOLE DAY. LOGFILE SHOWED MULTIPLE SUCCESSFULLY PERFORMED TREATMENTS. REPORTED TREATMENTS COULD BE IDENTIFIED IN THE LOGFILE. THE PATIENT INTERFACE (PI) WAS DOCKED SEVERAL TIMES ON THE LEFT EYE BECAUSE THE SURGEON HAD DIFFICULTIES WITH SUCTION ONE AND TWO. ON THE FIRST ATTEMPT, THE SURGEON ABORTED THE VACUUM PROCESS AFTER REACHING A VALID SUCTION ONE VALUE AND ON THE SECOND ATTEMPT, THE VALUE FOR SUCTION ONE WAS DROPPED. THEREFORE, THE SURGEON REPEATED VACUUM PROCESS AGAIN. ON THE THIRD ATTEMPT, THE SURGEON HAD DIFFICULTIES TO REACH A VALID SUCTION TWO VALUE AND INTERRUPTED THE VACUUM PROCESS. ON THE FOURTH ATTEMPT, VALID SUCTION VALUES WERE ACHIEVED AND THE TREATMENT OF THE LEFT EYE WAS SUCCESSFULLY COMPLETED. THE TREATMENT OF THE RIGHT EYE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE. THE USER OPERATED SURGERY WITHIN THE RECOMMENDED ENERGY SETTINGS. NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. HOWEVER, NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED. 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 DOCTOR REPORTED A CASE OF A STICKY FLAP ON ONE LEFT EYE THAT TORE WHILE TRYING TO LIFT. ADDITIONAL INFORMATION RECEIVED INFORMED THAT SUBSEQUENT SURGERY (EXCIMER LASER) WAS NOT PERFORMED AND THE PATIENT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595051 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other