MAUDE Adverse Event Report: Alcon Research, LLC - Huntington CLAREON PANOPTIX PRO Trifocal Intraocular Lens; Lens, Multifocal Intraocular

Model Number	PXYWT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implantation procedure, the patient experienced visual phenomena, including glare, halos, and blurry vision.The lens was explanted and replaced with an unspecified monofocal intraocular lens during a secondary surgical procedure.The clinical reason for explantation were reported as dysphotopia and visual side effects.Additional information has been requested.
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 PRO Trifocal 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 ; +1(800)757-9780
• MDR Report Key: 50814628
• Report Number: 1119421-2026-01900
• Device Sequence Number: 10697012
• Product Code: MFK
• UDI-Device Identifier: 00380658411060
• UDI-Public: (01)00380658411060(17)310106(11)260108(10)16179198
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: PXYWT0
• Device Catalogue Number: PXYWT0.205
• Device Lot Number: 16179198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/08/2026
• 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: CNA0T0 unspecified diopter and SN.; MONARCH III IOL Delivery System, Cartridge D.; MONARCH III IOL Delivery System, Injector.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown