BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 9107525 · Received September 23, 2019

    Report

    Report Number
    3006695864-2019-00777
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    August 17, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AN APPLICATION SUPPORT MANAGER (ASM) VISITED SITE AND GELLED THE SYSTEM. DURING VISIT, OBSERVED CONSTRUCTION OCCURRING ON 1ST FLOOR. THE STAFF STATED THE AIR FILTER IN LASER SUITE IS PLANNED TO BE REPLACED ON 9/3/2019. THE SURGEON STATED THE LASER SUITE/OR HAS SEPARATE VENTILATION THAN REST OF BUILDING. OBSERVED INSTRUMENTS ARE CLEANED WITH ALCOHOL AND THEN RINSED WITH STERILE WATER. THE LASER OPERATOR STATED THEY USE A NEW SET OF OPERATIVE EYE DROPS EACH SURGERY DAY. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT HOWEVER, PROACTIVELY REPLACED THE SATURABLE ABSORBER ASSEMBLY. 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LASER VISION CORRECTION PATIENTS HAD HAD SURGERY ON (B)(6) 2019 AND PRESENTED AT 1 DAY POST OP WITH DIFFUSE LAMELLAR KERATITIS (DLK) POST TREATMENT ON A FEW PATIENTS. DLK RESOLVED WITHIN 3 DAYS TO 1 WEEK POST OP FOR ALL PATIENTS BY INCREASING STEROID EYE DROP USE. DOCTOR STATED THE DRY AUTOCLAVE IS SERVICED REGULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898616 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention