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	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following an intraocular lens (iol) implantation procedure, the patient experienced glare, halos affecting his daily life, and his vision was unacceptable and uncomfortable to drive at night.The iol was replaced with a company monofocal iol 10 months, 6 days after the initial implant procedure.The clinical reason for explant was positive dysphotopsia.The surgeon¿s prognosis indicated a good postoperative appearance.Additional information has been requested however no further information available.
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
There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Corrected information provided in b.5.Additional information was provided in h.6., and h.11.The lens was returned in a specimen cup.Blood and solution was dried on the lens.One haptic was broken (possibly cut) from the haptic/optic junction area.The optic was cut in half, typical of insertion and removal.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 23.5 diopter (add power +2.2/+3.2) lens was replaced with a monofocal company lens with 23.5 diopter lens.Due to the exchange 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.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: 22608601
• Report Number: 1119421-2025-02049
• Device Sequence Number: 13162584
• Product Code: MFK
• UDI-Device Identifier: 00380652413718
• UDI-Public: (01)00380652413718(17)271126(11)231128(10)15757886
• 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: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: CCWTT0.235
• Device Lot Number: 15757886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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: GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male