BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8813921 · Received July 22, 2019

    Report

    Report Number
    3006695864-2019-00604
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 27, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 A COMPONENT. A FIELD SERVICE CHECKLIST WAS PERFORMED AND REPLACED THE GALVO BLOCK TO REPLACE THE ISSUE. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. 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): DATE CHANGED TO 12/15/2011. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED AN INCOMPLETE FLAP DURING THE LASER TREATMENT. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE LASER RASTER SEGMENT STARTED IN THE MIDDLE OF THE EYE AND THERE WAS XY GALVO ERRORS. THE LASER TREATMENT WAS ABORTED. THE LASER TREATMENT WAS RESCHEDULED AND COMPLETED ON A SECOND VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605540 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PATIENT INTERFACE