NutrifillRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00850012123002), received between Jan 5, 2022 and Jun 25, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K181566); they may or may not involve this specific model.

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.

Recalls naming this device

1. May 15, 2025Open, Classified

   Contact lens insertion solution may lack sterility.

   Z-1956-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT (B)(6) INDICATED THAT THEY HAD AN ULCER AND AN INFECTION IN THEIR EYES AND SPENT APPROXIMATELY 4 MONTHS RECOVERING. (B)(6) INDICATED THAT AFTER INSERTING THEIR CONTACT LENSES, THEY NOTICES THEIR EYES GETTING RED AND IRRITATED. AS THE DAY PROGRESSED, THE REDNESS AND IRRITATION GREW WORSE LEADING THEM TO REMOVE THEIR CONTACT LENSES AND VISIT THE EMERGENCY ROOM WITH UNBEARABLE PAIN. (B)(6) INDICATED THAT THE DOCTOR SAID THEY HAD AN EYE INFECTION COUPLED WITH A CUT (ABRASION) TO THEIR CORNEA.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22327235 ↗
• InjuryJun 25, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT LI INDICATED THAT THEIR RIGHT EYE WAS RED AND IRRITATED FOR A WEEK AND BECAME VERY BAD ON (B)(6) 2024. LI WENT TO URGENT CARE AND SAW THEIR DOCTOR WHO PRESCRIBED CIPRO AND LOTEMAX. LI INDICATED THAT THE REDNESS DID NOT IMPROVE FOR WEEKS AND THEIR DOCTOR FOUND THAT A COLONY HAD INFILTRATED THE CORNEA OF THEIR RIGHT EYE AND GAVE A SAMPLE OF BEVIMAX. AFTER A COUPLE OF WEEEKS, THE RIGHT EYE IMPROVED HOWEVER REDNESS RETURNED TO BOTH EYES. AFTER SWITCHING FROM NUTRIFILL TO LACRIPURE AND ADDIPAK, THE REDNESS STOPPED.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22326735 ↗
• InjuryJun 24, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT (B)(6) INDICATED THAT THEY HAD EXPERIENCED EYE PAIN AND BURNING/STINGING IN RIGHT EYE, ESPECIALLY WHEN BLINKING. THE PAIN SUBSIDED WHILST WEARING LENSES DURING THE DAY BUT LATER GOT WORSE. (B)(6) INDICATED THAT THEY VISITED THEIR DOCTOR THE FOLLOWING DAY AND WAS DIAGNOSED WITH A CORNEAL ULCER.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22318874 ↗
• InjuryJun 23, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT (B)(6) INDICATED THAT ON (B)(6) 2024, THEIR EYES WOULD START FEELING GRITTY AND RED AFTER 6 HOURS, EVENTUALLY LEADING TO EYE PAIN. LENSES KEPT GETTING HARDER TO WEAR FOR MORE THAN A FEW HOURS AT A TIME, EVENTUALLY GETTING EXTREME EVEN WITHOUT CONTACT LENSES. (B)(6) WAS GIVEN DROPS BY DOCTOR ON (B)(6) AND WAS ADVISED TO START WEARING CONTACT LENSES AGAIN AFTER A COUPLE OF WEEKS. (B)(6) INDICATED THAT THEY TRIED TO WEAR CONTACT LENSES AGAIN AND COULD ONLY DO SO FOR 4 HOURS WITHOUT EXTREME PAIN AND REDNESS. (B)(6) RETURNED TO THE DOCTOR AND CONFIRMED INFECTIONS IN BOTH EYES, GIVING (B)(6) MORE DROPS. AFTER A FURTHER COUPLE OF WEEKS, THE INFECTION CLEARED UP. (B)(6) WAS ADVISED TO CHANGE OUT ALL DROPS FOR NEW BOTTLES AND TRY AGAIN BUT THE INFECTION RETURNED WITHIN A COUPLE OF HOURS OF WEAR. (B)(6) RETURNED TO THE DOCTOR AND RECEIVED DROPS WITH THE DOCTOR NOTING THE BEGINNINGS OF CORNEAL TEARING OR SCARRING, HOWEVER (B)(6) SAW A DIFFERENT DOCTOR A WEEK LATER WHO DID NOT OBSERVE THIS. BY THE END ON (B)(6) 2024, (B)(6) WAS ADVISED BY THE DOCTOR TO STOP WEARING CONTACT LENSES FOR THE TIME BEING.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22307583 ↗
• InjuryJun 20, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT (B)(6) INDICATED THAT THEY HAD EXPERIENCED AN EXTREMELY RED AND BURNING EYE ON (B)(6) 2025. (B)(6) INDICATED THAT THEIR DOCTOR CONFIRMED AN ULCER AND PRESCRIBED MEDICATION DROPS. (B)(6) INDICATED THAT THEY SWITCHED FILLING SOLUTION AND HAVE NOT HAD ANY FURTHER ISSUES.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22297683 ↗
• InjuryJun 20, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT SM INDICATED THAT THEY HAD RECENTLY EXPERIENCED SEVERAL EYE ISSUES AND HAD VISITED THEIR DOCTOR TWICE DUE TO EYE INFECTIONS. RED EYE/LIGHT SENSITIVITY TREATED FOR AN ABRASION INITIALLY AND THEN FOR "DRY IRRITATED EYES" AND WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22297116 ↗
• InjuryJun 20, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PATIENT RG INDICATED THAT THEY HAD RECENTLY HAD AN EYE INFECTION AND HAD TO STOP USING THEIR CONTACT LENSES. RG INDICATED THAT THEIR EYES BECAME VERY RED WITH RED CIRCLES AROUND BOTH EYES. RG SAW THEIR DOCTOR ON (B)(6) 2025 AND WAS ADVISED THAT THERE WAS AN INFECTION AND POSSIBLY AN ULCER. RG WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 22296584 ↗
• InjuryDec 20, 2024Improper or Incorrect Procedure or Method; Microbial Contamination of Device; Improper or Incorrect Procedure or Method; Microbial Contamination of Device

  PATIENT (B)(6) CONTACTED THE COMPANY ON 11/13/2024 INDICATING THEY HAD RECENTLY BEEN TREATED FOR SEVERAL INFECTIONS. ON 11/14 (B)(6) AGREED TO A PHONE CALL TO DESCRIBE THE EVENT(S). (B)(6) BEGAN WEARING SCLERAL LENSES FOR KERATOCONUS IN (B)(6) OF 2024 (POST CORNEAL TRANSPLANT). (B)(6) USED UNIQUEPH DISINFECTING SOLUTION, NUTRIFILL SALINE SOLUTION FOR FILLING THEIR SCLERAL LENSES, AND SYSTANE PF DROPS AND AN UNKNOWN SALINE TO OCCASIONALLY RINSE LENSES. (B)(6) INDICATED THAT THEY WOULD USE ONE VIAL OF NUTRIFILL FOR 2-3 DAYS. SOMETIME IN AUGUST (B)(6) BEGAN TO EXPERIENCE IRRITATION, REDNESS AND PAIN OU WHEN WEARING LENSES. BY THE END OF AUGUST (B)(6) VISTED THEIR OPHTHAMOLOGIST FOR AN EMERGENCY VISIT. (B)(6) WAS ADVISED THEY HAD AN INFECTION FROM THEIR CONTACT LENSES AND WERE PRESCRIBED MOXYFLOXACIN AND TOLD TO DISCONTINUE WEAR FOR 10 DAYS UNTIL SYMPTOMS RESOLVED. (B)(6) RESUMED WEAR AFTER THE ADVISED TIME PERIOD AND IMMEDIATELY THE SYMPTOMS RESUMED AND THE OPTHTHAMOLOGIST AGAIN ADVICED TO DISCONTINUE CONTACT LENS WEAR, PRESCRIBED MOXYFLOXACIN AND REVIEWED DISINFECTION OF CONTACT LENSES AND TO REPLACE THEIR CONTACT LENS CASE AND SUGGESTED USING CLEARCARE TO DISINFECT LENSES. AFTER SSE

  Patient problems: Eye Infections; Eye Pain; Red Eye(s)

  MAUDE report 20994863 ↗
• InjuryMar 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  CL CALLED ON (B)(6) 2021 TO REPORT AN ADVERSE EVENT ON BEHALF OF TL. CL SAID THAT TL HAD BEEN FIT WITH A SCLERAL LENS IN ONE EYE AND RECEIVED SAMPLES OF THE SCLERAL LENS FILLING SOLUTION (NUTRIFILL) ON (B)(6) AND PURCHASED 3 CARTONS ON (B)(6) (DELIVERED (B)(6)). TL HAD SINCE BEEN TREATED FOR A CORNEAL ULCER, FUNGAL, AND PARASITE INFECTION AND SAW A CORNEAL SPECIALISTS (B)(6) FOR TREATMENT OF A CORNEAL ULCER. THEY HAD BECOME AWARE OF THE RECALL OF THE LOT FOE ON THE NOVEMBER 1ST (5TH NOTICE) AND CALLED AFTER NOTING THAT A CORNEAL ULCER RESULTING FROM A CORNAL ABRASION WAS A POTENTIAL RISK TO HEALTH. CL NOTED THAT THEY HAD NOT READ PREVIOUS NOTICES (FIRST NOTICE WAS (B)(6)). WHEN ASKED WHEN TL DISCONTINUED USING THE SOLUTION CL GUESSED THE BEGINNING OF JULY. WHEN ASKED HOW THE SOLUTION WAS BEING USED CL WAS UNSURE, WHEN ASKED IF THEY STILL HAD ANY PRODUCT LEFT CL SAID YES, AND COUNTED 2 FULL CARTONS AND ONE WITH 34 AMPOULES (ONE MISSING). CL WAS ASKED TO SEND THE REMAINING PRODUCT BACK TO BE EXAMINED AND WAS SENT A RETURN PACKAGE AND LABEL. CL WAS ALSO ASKED IF WE COULD SPEAK WITH TL'S DOCTOR(S) ABOUT WHAT HAPPENED AND IF SHE HAD CONTACTED ANY OF THEM REGARDING THE PRODUCT. CL SAID T

  Patient problems: Corneal Ulcer; Eye Infections

  MAUDE report 13944449 ↗
• InjuryJan 5, 2022Nonstandard Device

  USED NUTRIFILL SCLERAL LENS SOLUTION. DEVELOPED A CORNEAL ULCER OF LEFT EYE. STOPPED USING SOLUTION WHEN DEVELOPED SEVERE PAIN IN EYE AND SAW (B)(6), DO WHO REFERRED TO A CORNEAL SPECIALIST. SAW (B)(6), MD AT (B)(6) CENTER IN (B)(6). HAD WEEKLY APPOINTMENTS THRU SEPTEMBER. REFERRED TO (B)(6) AT (B)(6) CENTER. CULTURES WERE TAKEN AND REVEALED AN ACANTHAMOEBA PARASITE AND A CANDIDA TROPICALIS FUNGUS. IN THE MEANTIME OPENED AN EMAIL FROM THE NUTRIFILL COMPANY WHICH STATED THAT THE SOLUTION (UDI) (B)(4), LOT FOE (THE SOLUTION LOT THAT I HAD BEEN USING) HAD BEEN RECALLED DUE TO CAUSING CORNEAL ULCERS. I HAD NO PROBLEMS WITH THE SOLUTION WHEN USING THE SAMPLES THAT I RECEIVED WHEN FITTED WITH THE SCLERAL LENS (BY (B)(6), OD AT (B)(6) IN (B)(6)). IT WASN'T UNTIL I STARTED USING THE SOLUTION THAT I ORDERED ONLINE WHICH WAS THE ABOVE UDI AND LOT NUMBER THAT I STARTED HAVING PAIN WITHIN A COUPLE OF DAYS AND DEVELOPED THE ULCER AS STATED ABOVE. I HAVE BEEN SEEING PHYSICIANS WEEKLY EVER SINCE. I HAVE BEEN TOLD THAT I WILL NEED TO HAVE A CORNEAL TRANSPLANT IN THE FUTURE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Corneal Ulcer; Fungal Infection; Pain; Unspecified Infection

  MAUDE report 13178684 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181566. One submission often covers many models, so check the product and lot details in each record.

• Z-0030-2022 · Jul 27, 2021 · Terminated
  Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002