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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced vision was foggy, halos in daytime, cannot drive.Clinical reason being patient unhappy with vision afraid to drive due to halos.Explant was planned.There are two medical reports associated with this patient.This file belongs to right eye.Additional information has been received and the file has been updated accordingly.
Additional Manufacturer Narrative
A 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 device master record were met.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
Additional information received and reported that the iol was exchanged for the different lens model but more power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.
Additional Manufacturer Narrative
Corrected information was provided in b.6 and b.7.Additional information was provided in b.2., b.5., and h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury per regulation.No further reports required.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 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: 25475492
• Report Number: 1119421-2026-01262
• Device Sequence Number: 10352641
• Product Code: MFK
• UDI-Device Identifier: 00380658432942
• UDI-Public: (01)00380658432942(17)300928(11)250930(10)16118763
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: PXCWT0.185
• Device Lot Number: 16118763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 09/30/2025
• 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: ANTIBIOTIC DROPS; ARTIFICIAL TEARS DROPS; COMBO GTTS (PRED/MOXI/BROM); METHYLPREDNISOLONE DOSE PACK 4 MG TABLET; STEROID DROPS; SYSTANE DROPS; VISCOAT OVD
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female