BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL

    MDR report key: 8701212 · Received June 14, 2019

    Report

    Report Number
    3006695864-2019-00494
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 16, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND AN ISSUE WITH BSM IRIS. A FIELD SERVICE ENGINEER REPLACED THE BSM AND PERFORMED THE NECESSARY CALIBRATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE (MM/DD/YYYY): CHANGED TO MAY 11, 2007. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED GETTING AN IRIS MOTOR FAILURE ERROR MESSAGE WHEN THE DOCTOR ATTEMPTED TO START THE PROCEDURE. THE DOCTOR HAD ALREADY CREATED THE PATIENT FLAPS. THE PATIENT TREATMENT WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493407 S4-IR-ETL EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-4864 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention