BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8299011 · Received February 1, 2019

    Report

    Report Number
    3006695864-2019-00090
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 4, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)3370
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING DATE: THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS SEPTEMBER 11, 1998.

    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 · 1

    (B)(4). FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND ALIGNED TOTAL OPTICAL SYSTEM INCLUDING THE TRACKER CAMERAS. CONFIRMED AND VERIFIED LASER ASPIRATOR FLOW WAS SET PROPERLY AND ASPIRATOR NOZZLE WAS VERIFIED TO BE ALIGNED PROPERLY. PERFORMED IRIS CHECKS AT 1MM INCREMENTS. DISCOVERED IT WAS SLIGHTLY LARGER THAN EXPECTED BY .05 MM ON ALL CUTS OUT TO IN AND IN TO OUT ALTHOUGH WITHIN SPECIFICATIONS. PERFORMED IRIS CALIBRATIONS AND VERIFIED NEW SIZING WERE ACCURATE AS EXPECTED. REPLACED L2 OPTIC AND ROTATED M2 MIRROR DUE TO LOW L2 TRANSMISSION. 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 PATIENT PRESENTED WITH CENTRAL ISLAND POST TREATMENT. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92124 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other