BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8780340 · Received July 11, 2019

    Report

    Report Number
    3006695864-2019-00572
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 13, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A APPLICATION SUPPORT MANAGER ASM. THE ASM FOUND NO ISSUES WITH THE UNIT. THE LASER EQUIPMENT WAS GELLED SYSTEM WITH CURRENT USER SETTINGS. DURING Z-CALIBRATION, THE AVERAGE FLAP IN GEL WAS 130 MICRONS. THE LASER SYSTEM WAS FOUND TO BE WITHIN CLINICAL RECOMMENDATIONS. 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 6/20/2008. 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 HAD SURGERY ON (B)(6) 2019 AND EXPERIENCED A BUTTONHOLE IN THE PATIENT'S RIGHT EYE (OD). THE SURGERY CENTER INDICATED DURING THE DOCKING STAGE OF THE OD, THEY HAD TO RE-DOCK SINCE IT WAS NOT A GOOD INITIAL DOCK. UPON COMPLETION OF THE FEMTO LASER TREATMENT AND WHEN PATIENT WAS UNDER THE VISX EQUIPMENT, THE BUTTONHOLE WAS OBSERVED/NOTED. THE SURGEON ATTEMPTED TO LIFT THE FLAP BUT ABORTED THE TREATMENT. THE PLANNED TREATMENT WAS CONVERTED TO PHOTOREFRACTIVE KERATECTOMY (PRK). THE SURGERY CENTER INDICATED THE PROGRAMMED FLAP DEPTH WAS 120, HOWEVER, THE FLAP FELT VERY THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573181 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention PATIENT INTERFACE AND VISX LASER| PATIENT INTERFACE AND VISX LASER