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 Code	Visual Disturbances (2140)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced halos and eye fatigue after implantation.The iol was explanted in the secondary implant procedure.Additional information has been requested and received by stating there was no further impact to the patient.There are two medical reports associated with this patient.This is for left eye.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 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 ; +1(800)757-9780
• MDR Report Key: 50495777
• Report Number: 1119421-2026-01776
• Device Sequence Number: 10213964
• Product Code: MFK
• UDI-Device Identifier: 00380652413664
• UDI-Public: (01)00380652413664(17)271231(11)240102(10)15773294
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: CCWTT0
• Device Catalogue Number: CCWTT0.210
• Device Lot Number: 15773294
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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: MONARCH III IOL Delivery System, Cartridge D; MONARCH III IOL Delivery System, Injector; VISCOAT Ophthalmic ViscoSurgical Device
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown