MAUDE Adverse Event Report: MENICON CO., LTD. MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS; LENSES, SOFT CONTACT, DAILY WEAR

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Ulcer (1796); Red Eye(s) (2038); Corneal Infiltrates (2231)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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, and she was referred to medical facility c.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.

• Brand Name: MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• 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: 24450815
• Report Number: 1000188353-2026-00002
• Device Sequence Number: 21184833
• Product Code: LPL
• UDI-Device Identifier: 00884465091014
• UDI-Public: (01)00884465091014
• Combination Product (Y/N): N
• PMA/510(K) Number: K970019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/25/2026
• 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: Required Intervention; Disability; Other
• Patient Age: 73 YR
• Patient Sex: Female