BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 7773605 · Received August 10, 2018

    Report

    Report Number
    3006695864-2018-01661
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    July 16, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 NO ISSUES WITH THE UNIT. A FIELD SERVICE CHECKLIST WAS PERFORMED. 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 AND JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WHILE ON SITE PROVIDING SURGERY SUPPORT THE DOCTOR REPORTED THAT ONE PATIENT HAD VERTICAL GAS BREAKTHROUGH, DOCTOR INCREASED THICKNESS ON NEXT PATIENT AND THERE WERE NO FURTHER ISSUES. THE PATIENT WAS RESCHEDULED FOR PHOTOREFRACTIVE KERATECTOMY (PRK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613989 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention