BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 8198210 · Received December 26, 2018

    Report

    Report Number
    3006695864-2018-02246
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND CHECK LASER. ERROR LOG REPORTS SHOWED TWO ERROR 401''S ''ENERGY ERROR'' FOLLOWED BY ''ENERGY RECOVERY ERROR''. FSS OBSERVED THAT SYSTEM HAS NO ENERGY COMING FROM AMPLIFIER BUT IT HAS BOTH CURRENT AND HIGH VOLTAGE PRESENT. REPLACED AMPLIFIER ASSEMBLY. CONFIRMED AMP LOSES UPON START UP AT LOWER CURRENT SETTING OF 2.0MA AND POWER OUTPUT IS MEASURABLE. COMPLETED AMPLIFIER INTEGRATION INTO LASER ENGINE AND ADJUSTED ALIGNMENT THROUGH DELIVERY SYSTEM. COMPLETED AUTOCORRELATION. REQUESTED STAFF POWER UP SYSTEM ON MONDAY 12/3/2018 TO ENSURE NO ERRORS OBSERVED. RECEIVED EMAIL ON MONDAY (B)(6) 2018 FROM ACCOUNT THAT LASER HAD STARTED UP WITH NO ISSUES. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LASER STOP WHILE FIRING ON PATIENT¿S LEFT EYE WITH 2 SECONDS OF TREATMENT LEFT BECAUSE OF A MAX ENERGY LOW ERROR. SIDE CUT (FLAP SIDE CUT) WAS NOT DONE. STAFF WAS UNABLE TO RESET OR BYPASS FOR THE ERROR. PATIENT WAS REMOVED FROM BED AND PLACED IN SLIT LAMP AFTER UTILIZING FLUORESCEIN EYE STAIN FOR FURTHER EVALUATION DOCTOR MADE DECISION TO NOT ATTEMPT TO LIFT FLAP. PATIENT WAS SENT HOME WITH EXPECTATION THAT SURGERY WILL BE RESCHEDULED AT LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035545 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR