BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FML LIQUIFILM

    MDR report key: 6399084 · Received March 10, 2017

    Report

    Report Number
    MW5068402
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 9, 2017
    Manufacturer
    ALLERGAN
    Product Code
    HPX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A LASER SURGERY IN MY EYES (TO CORRECT VISION). ITS TYPE WAS PRK SURGERY. I WAS TOLD TO USE FML EYE DROPS. AFTER ALMOST A WEEK OF USE, I NOTICED SEVERE WRINKLES IN THE BOTTOM AND THE OUTER CORNERS OF MY EYES. I ASKED THE ADVISE OF THE DOCTOR BY PHONE AND HE TOLD TO CONTINUE USING THE PRODUCT. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. DO YOU STILL HAVE THE PRODUCT IN CASE WE NEED TO EVALUATE YET: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177701 FML LIQUIFILM WETTING SOLUTION HPX ALLERGAN E79425

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other