MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon PanOptix Trifocal Hydrophobic Intraocular Lens; Lens, Multifocal Intraocular

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Uveitis (2122); Visual Disturbances (2140); Eye Irritation (4803)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced an inflammatory reaction approximately one week after implantation, with inability of the iris to dilate normally, accompanied by photophobia and discomfort when transitioning from light to dark environments and vice versa.The reaction was diagnosed by the treating physician as iritis and was managed with anti-inflammatory treatment.The surgeon suspected a potential issue related to the lens material and requested further investigation.Additional information has been requested and received stating that that anti-inflammatory treatment, including a fluoroquinolone antibiotic plus corticosteroid, a non-steroidal anti-inflammatory drug, and a corticosteroid (glucocorticoid).No explantation procedure was performed.The patient had not returned for a follow-up visit, as the patient chose to continue care with another healthcare professional.No information was available regarding the patient¿s current condition.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon PanOptix Trifocal Hydrophobic Intraocular Lens
• Common Device Name: Lens, Multifocal Intraocular
• Manufacturer (Section D): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50932707
• Report Number: 9612169-2026-02230
• Device Sequence Number: 21209553
• Product Code: MFK
• UDI-Device Identifier: 00380652408172
• UDI-Public: (01)00380652408172(17)290521(11)250523(10)26042528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.225
• Device Lot Number: 26042528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/23/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EyeFill 2% B&L; MONARCH II IOL Delivery System, Injector; MONARCH III IOL Delivery System, Cartridge D; OcuCoat 2% B&L
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown