MAUDE Adverse Event Report: MENICON CO., LTD. MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS; LENS, CONTACT (OTHER MATERIAL) - DAILY

Lot Number	CG9P00722
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Ulcer (1796)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
• Common Device Name: LENS, CONTACT (OTHER MATERIAL) - DAILY
• Manufacturer (Section D): MENICON CO., LTD.; 21-19 aoi 3; naka-ku; nagoya, 460-0 006; JA 460-0006
• Manufacturer (Section G): MENICON CO., LTD., SEKI PLANT; 3; shinhasama; seki, gifu 501-3 923; JA 501-3923
• Manufacturer Contact: momoka okajima ; 21-19 aoi 3; naka-ku; nagoya, 460-0-006 ; JA 460-0006
• MDR Report Key: 24397963
• Report Number: 1000188353-2026-00001
• Device Sequence Number: 10113226
• Product Code: HQD
• UDI-Device Identifier: 00884465091014
• UDI-Public: (01)00884465091014
• Combination Product (Y/N): N
• PMA/510(K) Number: K962006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: CG9P00722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female