MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT3
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Macular Edema (1822); Vitreous Floaters (1866); Visual Impairment (2138)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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 non-healthcare professional reported that, following a cataract surgery with intraocular lens (iol) implantation, the patient was dissatisfied with their vision, describing it as bubbly and reporting floaters.Clinical reason being mentioned as cystoid macular edema post cataract surgery.The iol was explanted and exchanged with an unspecified monofocal intraocular lens in the secondary implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in b.3., b.6., b.7.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received by stating, there was no further impact to the patient.The iol was replaced with different model and different diopter of company lens.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23367605
• Report Number: 1119421-2025-02762
• Device Sequence Number: 21052598
• Product Code: MJP
• UDI-Device Identifier: 00380652468350
• UDI-Public: (01)00380652468350(17)260831(11)220902(10)15450233
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 08/31/2026
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.110
• Device Lot Number: 15450233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 11/21/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/16/2025
• Date Device Manufactured: 09/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF MULTIPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORCEPS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown