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	Blurred Vision (2137)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported an explanted iol with patient reason as vision was blurry distance and near.Clinical reason being patient unable to adapt to technology.The iol was explanted and exchanged for a non-company lens following the initial implant procedure.There was no further impact to the patient.Distance va was good, unable to read was reported.Patient would need reading glasses.Symptoms were continuing.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned submerged in clear solution inside a small, glass specimen jar.The lens was removed from the liquid and cleaned with klrp (klotho-related protein klrp) for evaluation.No lens damage was observed.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.The lens power and resolution were re-verified.The lens met specification for power and resolution.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.A qualified cartridge and handpiece were used with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.No problems were found with the returned product.The lens power and resolution were re-verified.The lens met specification for power and resolution.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.Information was provided that the patient was unable to adapt.The ccwtt0, 21.0 diopter (add power +2.17/+3.25), was replaced with a non-company 20.5 monofocal lens.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: 23290122
• Report Number: 1119421-2025-02695
• Device Sequence Number: 4889906
• Product Code: MFK
• UDI-Device Identifier: 00380652413664
• UDI-Public: (01)00380652413664(17)271231(11)240102(10)15768655
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 10/14/2025

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: CCWTT0.210
• Device Lot Number: 15768655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: HEALON.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; UNSPECIFIED FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male