BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 7920575 · Received September 28, 2018

    Report

    Report Number
    3006695864-2018-01934
    Event Type
    Injury
    Date Received
    September 28, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573475
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS NOT INCLUDED IN INITIAL REPORT THE CODES FOR THE ENVIRONMENTAL ISSUES FOUND BY THE FIELD SERVICE SPECIALIST AND THE OPTICAL PROBLEM THAT WAS FOUND BY HIM DUE TO THE HOT CONDITIONS.

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT UNKNOWN/NOT PROVIDED. (B)(4). FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND ON ARRIVAL, ALL GEL TESTS WERE GOOD AND Z CALIBRATION NEED TO BE CARRIED OUT. FSS COMPLETED FULL PREVENTIVE MAINTENANCE (PM) CHECKS AND CALIBRATIONS. DURING PM, IT WAS NOTICED THAT THE BEAM SHAPE WAS LESS ROUND THAN EXPECTED, AND THAT THE SYSTEM ENERGY HAD DROPPED. FSS FOUND DAMAGED AMPLIFIER GLASS WITHIN THE AMPLIFIER, MOST LIKELY CAUSED BY THE HOT ROOM CONDITIONS DUE TO THE RECENT HOT WEATHER. FSS REPLACED THE AMPLIFIER GLASS AND ALIGNED THE AMPLIFIER. FSS ALSO REALIGNED THE STRETCHER AND COMPRESSOR TO IMPROVE THE BEAM SHAPE. Z CALIBRATION TESTS ON CUSTOMER CONES SHOWED THEM AT THE LOWER END BUT WITHIN SPECIFICATIONS. FSS REDID THE Z CALIBRATION TO CENTER THEM WITHIN TOLERANCE RANGE. FSS COMPLETED ALL NECESSARY CHECKS AND CALIBRATIONS AND THE SYSTEM MEETS ALL JOHNSON & JOHNSON SURGICAL VISION (JNJSV) SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASER WAS CREATING FLAPS EITHER THICKER OR THINNER THAN EXPECTED WITH OPAQUE BUBBLE LAYER. A PATIENT THAT HAD LASER VISION CORRECTION HAD A VERTICAL GAS BREAKTHROUGH. PATIENT IS CURRENTLY DOING WELL AND HAS BEEN RETREATED SINCE SURGEON CREATED A FLAP AT A DEEPER LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759975 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC J20007K 05050474573475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention