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Tangible Fill Tangible Fill SalineRecalls & reported problems

Dry Eye Innovations, LLC · Sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. · Class 2

Adverse event reports
12
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00198168143803), received between Nov 6, 2025 and Nov 6, 2025 — classified as 12 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 12 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem12

Patient problems

  • Eye Infections12
  • Tissue Irritation12

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493343 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493341 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493339 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493338 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493337 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493336 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493334 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493331 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493329 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493328 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23493327 ↗
  • InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Eye Infections; Tissue Irritation

    MAUDE report 23491239 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.