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)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implantation procedure, the patient experienced glare/halos and can't drive at night or in rainy conditions.Additional information was received that carbachol (2.75%) and brimonidine tartrate (0.1%) in combination drops were prescribed as medication to help with glare and halos.The patient returned after a few days stating the drops might have been helping a little and was given the option of an iol exchange vs continuing to give it more time to adapt.The patient wished to give it more time and scheduled her next appointment later.There are two medical device reports associated with this patient.This report is associated with the right eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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 ; +1(800)757-9780
• MDR Report Key: 50053648
• Report Number: 9612169-2026-01718
• Device Sequence Number: 15832288
• Product Code: HQL
• UDI-Device Identifier: 00380658493103
• UDI-Public: (01)00380658493103(17)301002(11)251004(10)26121940
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: PXYAT0.110
• Device Lot Number: 26121940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 10/04/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown