MeniconZ (tisilfocon A) BlueRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884465091014), received between Dec 23, 2025 and Feb 25, 2026 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT OCCURRED IN JAPAN. [INFORMATION OBTAINED FROM THE PATIENT (DATE OF INFORMATION RECEIPT: 28 JANUARY 2026)]. THE PATIENT (PT) REPORTED THAT SHE HAD BEEN UNABLE TO USE CONTACT LENSES DUE TO AN EYE DISEASE (FUNGAL KERATITIS). DETAILS REGARDING HER SYMPTOMS AND TREATMENT COULD NOT BE CONFIRMED. PT FURTHER EXPLAINED THAT SHE HAD VISITED MEDICAL FACILITY B AND THE DOCTOR ADVISED HER TO RECEIVE FOLLOW UP EXAMINATIONS AT MEDICAL FACILITY C DUE TO THE SEVERITY OF HER CONDITION. IT IS NOTED THAT THIS INFORMATION WAS SELF-REPORTED BY THE PT, AND IT IS UNKNOWN WHETHER IT IS CONSISTENT WITH THE MEDICAL DIAGNOSIS. [INFORMATION OBTAINED FROM MEDICAL FACILITY B (DATE OF INFORMATION RECEIPT: 5 FEBRUARY 2026)]. ON (B)(6) 2025 (INITIAL VISIT), THE PATIENT VISITED MEDICAL FACILITY B AND WAS DIAGNOSED WITH A CORNEAL ULCER IN HER LEFT EYE. INFILTRATION WAS OBSERVED IN THE CENTRAL CORNEA, AND HER VISUAL ACUITY HAD DECREASED COMPARED WITH HER BASELINE UNCORRECTED VISUAL ACUITY. ON THE PREVIOUS DAY (ON (B)(6) 2025), SHE HAD BEEN PRESCRIBED 1.5% LEVOFLOXACIN, HYALURONIC ACID EYE DROPS, AND AN OPHTHALMIC OINTMENT AT MEDICAL FACILITY A. NO TREATMENT OR MEDICATION WAS PROVIDED AT MEDICAL FACILITY B,

  Patient problems: Corneal Infiltrates; Corneal Ulcer; Red Eye(s)

  MAUDE report 24450815 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT OCCURRED IN JAPAN. THE PATIENT (PT) REPORTED THAT SHE HAD BEEN UNABLE TO USE CONTACT LENSES SINCE (B)(6) 2025 DUE TO AN EYE DISEASE (CORNEAL ULCER). SYMPTOMS OCCURRED IN HER LEFT EYE. IN(B)(6) 2025, PT VISITED THE EMERGENCY DEPARTMENT AT MEDICAL FACILITY A AND WAS PRESCRIBED ANTIBACTERIAL AND ANTIBIOTIC OPHTHALMIC MEDICATIONS, AND SHE WAS INSTRUCTED TO STOP WEARING LENSES UNTIL RECOVERY. ALTHOUGH SHE INITIALLY EXPERIENCED REDUCED VISION, HER VISUAL ACUITY HAS GRADUALLY IMPROVED; HOWEVER, A CORNEAL ULCER STILL REMAINS ON HER CORNEA. ON (B)(6) 2026, PT VISITED MEDICAL FACILITY A AND THE DOCTOR ADVISED HER TO RECEIVE FOLLOW-UP EXAMINATIONS AT MEDICAL FACILITY B (PT'S REGULAR OPHTHALMOLOGY CLINIC). AT MEDICAL (B)(6), PT HAD PREVIOUSLY BEEN INFORMED THAT HARD CONTACT LENSES MAY NO LONGER BE SUITABLE FOR HER AGE, AND SHE HAD UNDERGONE MULTIPLE ADJUSTMENTS. SHE ALSO REPORTED A HISTORY OF SUSTAINING EYE INJURIES CAUSED BY HER LENSES. THE LENS INVOLVED IN THIS EVENT COULD NOT BE OBTAINED, AND THE LOT NUMBER OF THE LENS IS UNKNOWN. THEREFORE, A DETAILED INVESTIGATION COULD NOT BE CONDUCTED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATI

  Patient problems: Corneal Ulcer

  MAUDE report 24397963 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MENICON RECEIVED THE ACTUAL LENS FROM THE PATIENT AND CONDUCTED THE INVESTIGATION ON 02FEB2026. DETAILS OF THE INVESTIGATION RESULTS ARE SHOWN IN B6. THE CONCLUSION OF THE INVESTIGATION WAS THAT NO ABNORMALITIES WERE FOUND. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN RECEIVED TO DATE. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Corneal Scar; Corneal Ulcer; Excessive Tear Production; Eye Pain; Itching Sensation; Keratitis; Photophobia; Red Eye(s); Swelling/ Edema

  MAUDE report 23874428 ↗