FDA Adverse Event Injury Summary report: N

NUTRIFILL

MDR report key: 22106007 · Received May 29, 2025

Report

Report Number
MW5170870
Event Type
Injury
Date Received
May 29, 2025
Date of Event
November 13, 2024
Report Date
May 22, 2025
Manufacturer
CONTAMAC SOLUTIONS, INC.
Product Code
MRC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAVE EXPERIENCED PROGRESSIVELY WORSENING EYE PROBLEMS FOR THE PAST SIX MONTHS WHILE USING NUTRIFILL PRESERVATIVE-FREE SALINE SOLUTION (LOT HKK) BOTH TO RINSE AND--CRUCIALLY--TO FILL MY SCLERAL CONTACT LENSES. BECAUSE SCLERAL LENSES VAULT OVER THE CORNEA AND MUST BE FILLED WITH SALINE, MY EYES WERE IN CONSTANT CONTACT WITH THE CONTAMINATED SOLUTION THROUGHOUT EACH DAY. DURING THIS PERIOD, I DEVELOPED MULTIPLE EYE INFECTIONS, PERSISTENT REDNESS AND IRRITATION, A CORNEAL ULCER, NEW-ONSET HALOS AROUND LIGHTS, MEASURABLE DETERIORATION OF MY VISION IN BOTH EYES, AND FREQUENT HEADACHES FROM EYESTRAIN. AS SOMEONE WITH KERATOCONUS, MY CORNEAS ARE ESPECIALLY VULNERABLE TO CONTAMINATION. I HAD NEVER EXPERIENCED ANY OF THESE SYMPTOMS BEFORE USING THIS PRODUCT, WHICH I LATER LEARNED WAS NON-STERILE. ONCE I BECAME AWARE OF THE RECALL FOR STERILITY CONCERNS, I IMMEDIATELY DISCONTINUED USE--BY WHICH POINT I HAD ENDURED REPEATED INFECTIONS AND SIGNIFICANT VISION CHANGES. MY SYMPTOMS BEGAN SHORTLY AFTER I STARTED USING THE SOLUTION AND PERSISTED UNTIL I STOPPED IN (B)(6) 2025. I AM SUBMITTING THIS REPORT TO DOCUMENT THE FULL EXTENT OF THESE ADVERSE EFFECTS AND TO HELP ENSURE THAT OTHERS ARE NOT HARMED BY THIS PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
35278 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC.

Patients

Seq Age Sex Outcome Treatment
1 46 YR Male Disability