BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22575620 · Received July 23, 2025

    Report

    Report Number
    MW5173097
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    March 15, 2025
    Report Date
    July 19, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CORNEAL EDEMA BOTH EYES. I HAD A MONTH OF DECREASED VISION BEFORE SEEING MY DOCTOR FOR RECHECK/REFRACTION. MY PRESCRIPTION GLASSES WERE NO LONGER LEGAL FOR DRIVING AND MY EYES WERE TOO IRRITATED TO WEAR MY SCLERALS. I HAD USED TWO BOXES OF NUTRIFILL BEFORE RECALL. I HAVE ONE SAMPLE PACK UNOPENED THAT WAS UNDER RECALL. TO FILL SCLERAL LENSES. REFERENCE REPORTS: MW5173098, MW5173099.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188179 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Disability| R