MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	PXCWT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation in left eye, the patient experienced extreme glare throughout the day and when driving at night.Subsequently the lens was removed and replaced with a non-company lens of one diopter more power in a secondary procedure.There was no further impact to the patient.
Additional Manufacturer Narrative
The lens was returned on a surgical sponge.Blood and solution was dried on the lens.The lens was cut in multiple pieces, 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.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.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, 21.5 diopter, add power +2.2/+3.2 lens model was replaced with a 22.5 diopter non-company monofocal lens.Due to the exchange from a multifocal lens to a 1.0 higher diopter 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).

• Brand Name: CLAREON PANOPTIX PRO 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: 25109327
• Report Number: 1119421-2026-00979
• Device Sequence Number: 18464839
• Product Code: MFK
• UDI-Device Identifier: 00380658432997
• UDI-Public: (01)00380658432997(17)300713(11)250715(10)16080613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: PXCWT0
• Device Catalogue Number: PXCWT0.215
• Device Lot Number: 16080613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male