MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Description of Event or Problem

MENICON IDENTIFIED THE POSSIBLE RELATED LOT BASED ON THE DELIVERY HISTORY AND CONDUCTED THE INVESTIGATION ON (B)(6) 2026. 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.

Description of Event or 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 INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.