BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 9559990 · Received January 7, 2020

    Report

    Report Number
    3006695864-2020-00015
    Event Type
    Injury
    Date Received
    January 7, 2020
    Report Date
    November 5, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H4. DEVICE MANUFACTURE DATE - 09/21/2011.

    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. INITIAL REPORTER PHONE NUMBER: UNKNOWN/NOT PROVIDED. MANUFACTURING DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4). FIELD SERVICE ENGINEER (FSE) VISITED ACCOUNT AND CHECKED THE LASER. FSE REPLACED OBJECTIVE AND ANALOG I/O PRINTED CIRCUIT BOARD FOR TROUBLESHOOTING. NO FAILURE WAS DETECTED. 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

    CUSTOMER COMPLAINED OF BUBBLE LAYER IN THE CORNEAL FLAP INTERMITTENTLY. THE BUBBLE LAYER IS DETECTED DURING LIFTING OR AFTER LIFTED THE FLAP AND LOCATED IN THE OPPOSITE SIDE OF THE SUPERIOR HINGE OR SOMETIMES IN THE CENTER. WITH THE RESPECT OF THE CORNEA LAYERS, CUSTOMER SAYS, IT IS OCCURRED BETWEEN EPITHELIUM & BOWMAN'S MEMBRANE WITH NOTICEABLE SIZE AND IT AFFECTS TO THE VISION WITH LONGER RECOVERY TIME IF LOCATED IN THE CENTER. IT WAS REPORTED THAT PATIENT REQUIRED FLAP LIFTED / RINSED / SCRAPPED. THIS REPORT IS FOR PATIENT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20004 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007K 05050474573475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention