BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 13488241 · Received February 8, 2022

    Report

    Report Number
    3012236936-2022-00272
    Event Type
    Injury
    Date Received
    February 8, 2022
    Report Date
    February 8, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, SEX, WEIGHT AND ETHNICITY ARE UNKNOWN/NO INFORMATION HAS BEEN PROVIDED. DATE OF EVENT IS UNKNOWN. (B)(6). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT. ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND PERFORMED FULL SYSTEM CHECKOUT. THE FSE CUT SOME GELS WITH THE GANTRY TO THE LEFT AND ALSO TO THE RIGHT. THE RESULTS WERE IDENTICAL. THE FSE FOUND NO ISSUES WITH THE SYSTEM. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OVER THE PAST 10 MONTHS, 12-14 LEFT EYES HAVE EXPERIENCED LATE ONSET DIFFUSE FIBROSIS. IT OCCURRED AT LEAST ONE MONTH POSTOPERATIVELY, REMAINS STABLE AND HAS NOT LED TO ANY VISION LOSS, ANY SIGNIFICANT DEBRIS/EPITHELIAL CELLS/DIFFUSE LAMELLAR KERATITIS (DLK). THERE IS NOT IMPROVEMENT WITH STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903558 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention