BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGILE FILL

    MDR report key: 23491239 · Received November 6, 2025

    Report

    Report Number
    1417519-2025-00001
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 23, 2025
    Manufacturer
    AMSINO HEALTHCARE (USA) INC.
    Product Code
    MRC
    UDI-DI
    00198168143803
    PMA / PMN Number
    K201069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE END USER RETURNED 48 OF THE 60 VIALS FROM THE CASE, WHICH AMSINO RECEIVED ON 14-AUG-2025. INITIAL FINISHED-PRODUCT TESTING FOR LOT L095, INCLUDED ASSAY, USP <71> STERILITY, AND USP <85> BACTERIAL ENDOTOXINS TESTING. TO OBTAIN MULTI-LABORATORY CONFIRMATION, AMSINO SUBMITTED A SUBSET OF THE RETURNED COMPLAINT SAMPLES FROM L095 TO A DIFFERENT LABORATORY FOR USP <71> STERILITY AND USP <85> ENDOTOXIN TESTING. USP <85> RESULTS WERE RECEIVED ON (B)(6) 2025 AND MET SPECIFICATION; USP <71> RESULTS WERE RECEIVED ON 31-OCT-2025 AND WERE NEGATIVE. IN ADDITION, RETENTION SAMPLES FROM THE SAME LOT WERE TESTED USING THE SAME METHODS, AND ALL RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    THE END USER REPORTED: I WAS A USER OF NUTRIFILL UNTIL I GOT THE RECALL NOTICE. I DISPOSED OF ALL REMAINING NUTRIFILL PRODUCT AS RECOMMENDED. UNFORTUNATELY I NEEDED TO REPLACE MY SCLERAL SOLUTION RIGHT AWAY AND IT WOULD HAVE TAKEN TOO LONG FOR IT TO ARRIVE FROM THE TANGIBLE SCIENCE WEBSITE. I ORDERED IT FROM AMAZON SO THAT I COULD GET IT ASAP SO I COULD CONTINUE WEARING MY SCLERALS (REQUIRED FOR MY VISION). THE FIRST DAY I USED TANGIBLE FILL, MY EYES WERE SLIGHTLY IRRITATED BY THE END OF THE DAY. I ASSUMED THIS WAS JUST ADJUSTING TO THE NEW PRODUCT. BY DAY 5, MY EYES WERE INFECTED (RED, DRAINING, AND GUNKY). FOLLOW UP MESSAGE FROM END USER: I GOT SOME EYE MEDICATION AND THE INFECTION HAS CLEARED UP. I STARTED USING A DIFFERENT PRODUCT (BRAND) AND HAVE HAD NO FURTHER ISSUES. I HAVE THE REMAINING PRODUCT IF YOU NEED TO HAVE IT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385984 TANGILE FILL SCLERAL SALINE 5ML MRC AMSINO HEALTHCARE (USA) INC. 2490 L095 00198168143803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other