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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Dry Eye(s) (1814); Macular Edema (1822); Uveitis (2122); Blurred Vision (2137); Visual Impairment (2138); Vitreous Detachment (2445); Eye Pain (4467); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report originally filed as 9612169-2026-00559 the product was not returned.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.The product investigation could not identify a root cause for the reported complaint.The product has not been received to evaluate.The consumer was advised to speak to surgeon regarding issues they are experiencing or seek a second opinion.Company is unable to provide medical advice or recommendations.Consumer was advised an investigation will be performed on the serial number of the implanted lens.Consumer was asked to contact company should additional details become available.Patient educational materials emailed.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that the patient saw her eye doctor a few days after surgery due to inflammation, blurred and poor vision, eye pain, discomfort, swelling, edema, and has been treated many times since then for the same issues.She was treated for severe dry eyes with non preservative drops, warm compresses, and amp.It felt like she had something in her eyes that was not supposed to be there, which was confirmed by the doctor.Additionally, upon further follow up patient also had nuclear sclerosis, posterior vitreous detachment, acute iritis, secondary noninfectious iridocyclitis, cystoid macular edema, high myopia and underwent cam360 amnio graft recently, and it helped a little but did not last.Today, the patient reported that she had an irritation, blurred vision, burning, watering or tearing, itching, amp, pain in her eyes with headache with the slightest movement of her head.Additional information has been requested, yet no new information received.There are two medical reports associated with this patient.This file belongs to right eye.

• 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: 24816439
• Report Number: 1119421-2026-00709
• Device Sequence Number: 14955406
• Product Code: MFK
• UDI-Device Identifier: 00380652413626
• UDI-Public: (01)00380652413626(17)260409(11)220411(10)15382547
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Expiration Date: 04/09/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.190
• Device Lot Number: 15382547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 04/11/2022
• 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: Female