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	09/30/2024
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, after intraocular lens implantation surgery, the patient experienced glare, halos.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was dysphotopsia and halos.
Additional Manufacturer Narrative
Correction information was provided in a2., a3.A., b.3., b.5., b.6., d.10., e.1.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, in the surgeon's opinion, the cause of the event was non adapt.After the exchange the patient issue was resolved after the exchange and the patient able to drive and happier.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The sample was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The cartridge and handpiece information was not provided.It is unknown if qualified products were used.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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.The 20.5 diopter (add power +2.17/+3.25 diopter) lens was removed and replaced with a noncompany monofocal 21 diopter lens.Due to the exchange of a multifocal 20.5 diopter lens to a noncompany monofocal 21.0 diopter lens may suggest that the change from a multifocal lens to a monofocal lens and a 1/2 diopter larger for the replacement lens was an improved selection for this patient's vision needs.No further information has been provided.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: 23365145
• Report Number: 1119421-2025-02750
• Device Sequence Number: 18362645
• Product Code: MFK
• UDI-Device Identifier: 00380652413657
• UDI-Public: (01)00380652413657(17)270201(11)230203(10)15570979
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.205
• Device Lot Number: 15570979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 11/20/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/14/2025; 12/16/2025
• Date Device Manufactured: 02/03/2023
• 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: AMVISC OVD; UNSPECIFIED HANDPIECE AND CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male