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

Model Number	PXYAT0
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
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 consumer called to report she was having extreme halos at night, causing difficulty in driving and having shadows behind letters when trying to read.Distance vision during the day was good.Had spoken to her surgeon, he had treated for dry eye and determined she did not have dry eye.Had been treated with a drug which belongs to the miotics to reduce pupil size which had not helped.Additional information has been requested.There are two medical reports associated with this patient.This file is for right eye.

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 24220687
• Report Number: 9612169-2026-00202
• Device Sequence Number: 15475153
• Product Code: HQL
• UDI-Device Identifier: 00380658493301
• UDI-Public: (01)00380658493301(17)300417(11)250419(10)26025941
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: PXYAT0
• Device Catalogue Number: PXYAT0.210
• Device Lot Number: 26025941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 04/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female