BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGILE FILL

    MDR report key: 23493331 · Received November 6, 2025

    Report

    Report Number
    1417519-2025-00004
    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 22-OCT-2025 AND MET SPECIFICATION; USP <71> RESULTS WERE RECEIVED ON (B)(6) 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
    173834 TANGILE FILL SCLERAL SALINE 5ML MRC AMSINO HEALTHCARE (USA) INC. 2490 L095 00198168143803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R