BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22576892 · Received July 23, 2025

    Report

    Report Number
    MW5173131
    Event Type
    Injury
    Date Received
    July 23, 2025
    Report Date
    July 19, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING NUTRIFILL EXCLUSIVELY AS MY SCLERAL LENS SALINE FILLING SOLUTION. A FEW WEEKS BEFORE THE RECALL IN MAY, I WAS EXPERIENCING UNUSUAL REDNESS, PAIN AND IRRITATION IN BOTH EYES. I DO NOT KNOW FOR CERTAIN THAT IT WAS CAUSED BY THE NUTRIFILL (MY LOTS WERE NOT IN THE LIST OF RECALLED LOTS) BUT IT IS DEFINITELY A POSSIBILITY AS MY EYES CLEARED UP AND THE SYMPTOMS RESOLVED UPON SWITCHING TO ANOTHER SALINE FILLING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591002 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DEXAMETHASONE.| SCLERAL LENSES.| VEVYE.