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	Blurred Vision (2137)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.The clinical reason for explant was that the patient was unable to adapt.The iol was exchanged for a non-company lens with a different diopter 14 days following the initial implant procedure.In the surgeon¿s opinion, the product did not cause or contribute to the event, and the event was due to a mechanical issue of non-adaptation.There was no further impact on the patient.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
The product was not returned for analysis; 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 medical device file were met.Root cause has not been identified.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 ; +1(800)757-9780
• MDR Report Key: 50175752
• Report Number: 1119421-2026-01653
• Device Sequence Number: 12829706
• Product Code: MFK
• UDI-Device Identifier: 00380658433048
• UDI-Public: (01)00380658433048(17)300930(11)251002(10)16119340
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: PXCWT0.240
• Device Lot Number: 16119340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 10/02/2025
• 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: ETA 24.5 3R13834032 replacement lens.; Lens folding forceps.; MONARCH III IOL Delivery System, Cartridge C.; MONARCH III IOL Delivery System, Injector.; ORA System with VerifEye Messaging, Cart.; ORA System with VerifEye Messaging.; viscoelastic: stablevisc.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown