BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8556566 · Received April 26, 2019

    Report

    Report Number
    3006695864-2019-00335
    Event Type
    Injury
    Date Received
    April 26, 2019
    Report Date
    November 11, 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

    IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 09/30/2013, HOWEVER THE CORRECT DATE IS 09/04/2013. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. A FIELD SERVICE SPECIALIST VISITED SITE AND PERFORMED LASER CHECKS AND TESTED THE LASER. NO PROBLEMS FOUND. SYSTEM MEETS JOHNSON & JOHNSON SURGICAL VISION SPECIFICATIONS. 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 DOCUMENTATION 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 1 PATIENT HAD DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE (OS) WHICH OCCURRED PRIOR TO (B)(6) 2010 DATE OF SURGERY. THE PATIENT IS BEING TREATED WITH FLUOROMETHOLONE (FML) STEROIDS. DOCTOR HAD CHANGED FROM PREDNISOLONE ACETATE EYE DROPS TO FML DUE TO SHORTAGE OF PREDNISOLONE ACETATE. DOCTOR STARTED COMFORT EYE DROPS WHICH IS A COMBINATION OF PRESERVATIVE-FREE ARTIFICIAL TEARS AND ALCAINE GIVEN TO PATIENTS TO USE ON DAY OF SURGERY AFTER SURGERY HAS BEEN PERFORMED. THE COMFORT EYE DROPS WERE DISCONTINUED ON LAST SURGERY DAY, (B)(6) 2019. DLK HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346698 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention