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); Intraocular Pressure Increased (1937); Uveitis (2122); Blurred Vision (2137); Visual Impairment (2138); Vitreous Detachment (2445); Eye Pain (4467); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
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 ocular hypertension, nuclear sclerosis, posterior vitreous detachment, acute iritis, secondary noninfectious iridocyclitis, cystoid macular edema, high myopia, epiretinal membrane 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 left 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).

• 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: 24581171
• Report Number: 1119421-2026-00524
• Device Sequence Number: 13380776
• Product Code: MFK
• UDI-Device Identifier: 00380652413626
• UDI-Public: (01)00380652413626(17)260503(11)220505(10)15401549
• 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): 03/12/2026

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: 05/03/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.190
• Device Lot Number: 15401549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 05/05/2022
• 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: Required Intervention; Other
• Patient Sex: Female