BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22461405 · Received July 9, 2025

    Report

    Report Number
    MW5172479
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 6, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DIAGNOSED WITH EYE INFECTION. I'VE BEEN TREATED FOR SEVERAL EYE INFECTIONS SINCE I'VE STARTED WEARING SCLERAL LENSES IN FALL OF 2023 AND HAVE EXCLUSIVELY BEEN USING NUTRIFILL. NUTRIFILL SENT ME AN EMAIL TO RETURN THE 45 CAPSULES OF LOT HGI AND I THOUGHT I'D EMAIL YOU AS WELL. I SAID I'D RETURN THE VIALS TO THEM IN THE CUSTOMER EMAIL THEY SENT ME. ONCE I RECEIVED THE RECALL INFORMATION I REFLECTED ON THE SEVERAL EYE INFECTIONS I'VE BEEN TREATED FOR SINCE I'VE STARTED USING NUTRIFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601743 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC. HGI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention RESTASIS CEVIMELINE SYSTANE PRESERVATIVE FREE EYE DROPS.