BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 23015319 · Received September 10, 2025

    Report

    Report Number
    MW5175807
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 4, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COMPANY NAME: CONTAMAC SOLUTIONS, INC PRODUCT NAME: NUTRIFILL UNIQUE DEVICE IDENTIFIER (UDI): (B)(4) I PURCHASED MULTIPLE BOXES OF NUTRIFILL SOLUTION AND I HAVE USED THEM SINCE LAST YEAR. IN MAY I STARTED TO FEEL DISCOMFORT IN BOTH OF MY EYES. I EXPERIENCED REDNESS, BURNING SENSATION, DRYNESS AND IRRITATION. DURING MY EYE EXAM THE DOCTOR INFORMED ME THAT I HAD DEVELOPED EYE ULCERS THAT LEFT SCARS ON BOTH OF MY EYES. THE RIGHT EYE WAS MORE COMPROMISED THAN THE LEFT EYE. I WAS GIVEN STEROIDS TO TAKE FOR 10 DAYS. BASED ON THE LOCATION WHERE THE SCAR FORMED ON MY RIGHT EYE MY VISION WAS SIGNIFICANTLY IMPACTED. BASED ON THE DISTANCE TEST DONE ON MY RIGHT EYE MY VISION IS NOW 20/400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469460 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC. HKK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| S| O EXCEDRIN MIGRAINE.| SAM-E.