BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 7966144 · Received October 15, 2018

    Report

    Report Number
    3006695864-2018-02010
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION
    Product Code
    LZS
    UDI-DI
    00(01)(21)3458
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE SPECIALIST CONFIRMED THE SLIT MOTOR FAILURE. FSS REPLACED THE BEAM SHAPING MODULE (BSM) TO RESOLVE THE REPORTED PROBLEM. A FIELD SERVICE CHECKLIST WAS PERFORMED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS AFTER REPAIR. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A 93 SECOND TREATMENT, THE LASER STOPPED 30 SECONDS INTO THE TREATMENT WITH A SLIT MOTOR ERROR AND WAS UNABLE TO COMPLETE THE LEFT EYE (OS (OCULAR SINISTER)). THE RIGHT EYE (OD (OCULAR DEXTER)) WAS COMPLETED SUCCESSFULLY. A MICROKERATOME WAS USED IN BOTH EYES (OU (OCULAR UTERQUE)). RIGHT EYE POST OP UCVA 20/30. RIGHT EYE SCHEDULED FOR NEAR EYE/ MONOVISION. PRE OP BCVA 20/20. PATIENT WILL BE SEEN ON (B)(6) 2018 AND THEY WILL TRY AND ATTEMPT A BCVA NO FURTHER MEDICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808650 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION 0030-1479R 00(01)(21)3458

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR