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)
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced bcva reduced and visual disturbances and stated everything was blurry since surgery.Clinical reason being mentioned blurred vision.Yag procedure was completed.The patients condition was reported as undetermined and still waiting on ldd treatments.The surgeons prognosis reported as good postoperative appearance.The iol was explanted and exchanged with an non company lens in the secondary implant procedure.There was no further impact to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.Only half of the lens was returned in a specimen cup.Solution was dried on the lens.The lens was cut in half, typical of insertion and removal.The returned half of the lens had multiple small areas of starburst damage observed in the lens material of the optic, typical of damage caused by a yag laser procedure conducted post implantation.Power and resolution testing could not be conducted due to the extensive optic damage.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the extensive optic damage.The file indicated that the multifocal company lens with 22.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company monofocal 21.0 diopter lens.Due to the exchange for a 1.5 lower diopter difference lens and the change from a multifocal lens to a monofocal lens may suggest that the replacement lens model may have been an improved choice for the patient's vision needs.Information was provided on the completed questionnaire that the patient had prior "lasik¿ surgery.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 ; 8007579780
• MDR Report Key: 22588381
• Report Number: 1119421-2025-02038
• Device Sequence Number: 15800901
• Product Code: MFK
• UDI-Device Identifier: 00380652413695
• UDI-Public: (01)00380652413695(17)260615(11)220617(10)15431800
• 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: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 06/15/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.225
• Device Lot Number: 15431800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 06/17/2022
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male