BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FCI PROLONG (LEFT EYE)

    MDR report key: 17919842 · Received October 11, 2023

    Report

    Report Number
    MW5146802
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 7, 2023
    Manufacturer
    FCI OPHTHALMICS, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY OPTHALMOLOGIST PUT IN FCI OPTHALMICS 6-WEEK SILICONE TEAR DUCT PLUGS INTO BOTH MY EYES FOR DRY EYE. I WAS TOLD I SHOULDN'T FEEL THEM, BUT I FEEL THEM IN THERE LIKE OLD CONTACT LENSES, AND MY EYES ARE STILL DRY, NO CHANGES. WENT BACK TO MD (PHYSICIAN) WHO SAID MY EYES ARE OK, I AM THE FIRST COMPLAINT, ALL HIS PATIENTS WHO HAVE THEM NEVER COMPLAINED, AND PRESCRIBED ANTIBIOTIC EYE DROPS. I CALLED THE COMPANY TO ASK IF I SHOULD BE FEELING THEM AS IT'S IRRITATING, AND IF SOMETHING CAN BE DONE TO DISSOLVE THEM SOONER. THE COMPANY TOLD ME THEY DON'T SPEAK TO PATIENTS, THEY WILL ASK A REP TO CALL MY MD AND I NEED TO WORK WITH MY MD. I'D JUST LIKE TO KNOW IF I'M IN DANGER AS THIS IS MY EYES AND IT MUST HAVE HAPPENED BEFORE. THE PLUGS ARE STILL IN MY EYES AS I WAS TOLD THEY CANNOT BE REMOVED BUT IT SEEMS UNREALISTIC TO WAIT 6 WEEKS FOR THEM TO DISSOLVE. REFERENCE REPORT: MW5146803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133507 FCI PROLONG (LEFT EYE) PLUG, PUNCTUM LZU FCI OPHTHALMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown