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	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The optic is split from the edge across the center of the lens.A crack is observed on the optic near the edge and the split area.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.The file indicates the use of a qualified cartridge and handpiece.Information regarding the viscoelastic was not provided.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 file indicates that the company, 25.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company extended depth of focus lens with a difference of three diopters.Due to the exchange different multifocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, patient had starbursts with night driving and photopsia.The lens was exchanged with non-company iol following the initial implant procedure.Additional information has been requested.

• 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: 22480844
• Report Number: 1119421-2025-01900
• Device Sequence Number: 20956933
• Product Code: MFK
• UDI-Device Identifier: 00380652413756
• UDI-Public: (01)00380652413756(17)281013(11)241015(10)15937271
• 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: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: CCWTT0.255
• Device Lot Number: 15937271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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 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: 48 YR
• Patient Sex: Female