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	Blurred Vision (2137); Visual Disturbances (2140); Posterior Capsule Opacification (4807)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced glare.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was dysphotopsia.There was no patient harm.The surgeon's prognosis was bright light was still bothersome and vision was unclear and posterior capsule opacification.Hence yttrium aluminium garnet laser was performed.Additional information was received stating that, the she was doing great post exchange.No complaints issues with bright lights/halos and blurred vision was correctable with the patient's new glasses.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Only three pieces of the lens were returned.The piece that have been returned are split and cracked.A power and resolution inspection could not be conducted due to extensive damage.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.A power and resolution inspection could not be conducted due to extensive damage.The 22.0 diopter (add power +2.2/+3.2) lens was replaced with a 22.0 diopter of different lens model.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.Information in the file states that the patient is doing great post exchange.No complaint issues with bright lights/halos and blurred vision is correctable with the patient's new glasses.A yag (yttrium aluminum garnet) procedure was performed post exchange.File will be reopened if new information is received.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: 22235524
• Report Number: 1119421-2025-01688
• Device Sequence Number: 15497904
• Product Code: MFK
• UDI-Device Identifier: 00380652413688
• UDI-Public: (01)00380652413688(17)270422(11)230424(10)15636392
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.220
• Device Lot Number: 15636392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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: CLAREON ASPHERIC UV ABSORBING IOL.; MONARCH II LOADING FORCEPS.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; PROVISC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female