MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Root cause: root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, patient experienced blurry vision and constant headache.Clinical reason for explant was lens did not center well despite placement in the bag.The iol was exchanged for monofocal lens 2 years, 3 months days following the initial implant procedure.Additional information received and stated that in surgeon opinion the lens itself did not contribute to perceived decentration; the lens optics themselves ultimately contributed to the event (the diffractive optics just didn¿t work well in this eye subjectively - they worked surprisingly well in the other eye).
Additional Manufacturer Narrative
Correction information was provided in h.11.The product was not returned.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 25280317
• Report Number: 1119421-2026-01138
• Device Sequence Number: 9567771
• Product Code: MFK
• UDI-Device Identifier: 00380652413602
• UDI-Public: (01)00380652413602(17)270502(11)230504(10)15640628
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.180
• Device Lot Number: 15640628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/17/2026
• Date Device Manufactured: 05/04/2023
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown