BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22461315 · Received July 9, 2025

    Report

    Report Number
    MW5172477
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 4, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BEGAN EXPERIENCING INFECTION-LIKE SYMPTOMS, INCLUDING REDNESS, SWELLING, AND DISCOMFORT IN MY RIGHT EYE. I VISITED MY OPHTHALMOLOGIST IN MAY, WHO CONFIRMED SIGNS OF IRRITATION AND INFLAMMATION. THE SYMPTOMS PROGRESSIVELY WORSENED, ULTIMATELY RESULTING IN SIGNIFICANT VISION LOSS IN MY RIGHT EYE. THESE COMPLICATIONS CLOSELY MATCH THE SYMPTOMS OUTLINED IN THE PRODUCT RECALL. THE PAIN INCREASED, REDNESS INTENSIFIED, AND DISCHARGE DEVELOPED. I THEN WENT TO AN IMMUNOTHERAPY OPHTHALMOLOGIST WHO CONDUCTED CULTURES TO DETERMINE WHETHER THE INFECTION WAS BACTERIAL OR FUNGAL. THE CULTURES CONFIRMED A BACTERIAL INFECTION, AND I WAS DIAGNOSED WITH A CORNEAL ULCER. AS A RESULT, I AM NOW FACING THE NEED FOR A NEW CORNEAL TRANSPLANT. THE COMPLICATIONS I EXPERIENCED CLOSELY ALIGN WITH THOSE DESCRIBED IN THE RECALL NOTICE FOR THIS PRODUCT. I WEAR A SCLERAL CONTACT LENS IN RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601742 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention| S| O AZATHIOPRINE.| FOLIC ACID.| MULTIVITAMIN.| PREGABALIN.| ZYRTEC.