MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL TORIC UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	PXCAT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced severe dysphotopsias and starbursts and did not feel safe driving at night.The lens was explanted and replaced with a other company monofocal lens in a secondary procedure.The clinical reason for the explant was dysphotopsias.Additional information has been received as there was no further impact to the patient.

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL TORIC UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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 ; 8007579780
• MDR Report Key: 23787236
• Report Number: 9612169-2025-02484
• Device Sequence Number: 13379515
• Product Code: MJP
• UDI-Device Identifier: 00380658491338
• UDI-Public: (01)00380658491338(17)300222(11)250224(10)25988136
• 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: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: PXCAT3
• Device Catalogue Number: PXCAT3.205
• Device Lot Number: 25988136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 02/24/2025
• 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: INTREPID AUTOSERT IOL HANDPIECE; JJV DIU150 20.5 SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown