MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	PXCAT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced fuzzy vision, glare and halos and clinical reason for explant being mechanical complication of lens.The iol was explanted and exchanged for a non company lens following the initial implant procedure.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stating that the lens was cut into pieces to remove from the eye.There is no further impact to the patient.Issue was resolved and it was reported that there were no halos and clear vision.
Additional Manufacturer Narrative
Additional information has been provided in b.3., b.5., b.6., b.7., and d.10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information has been provided in h.11.Correction: on smdr1, the d.10 had been submitted with the associated products, which was removed as per further assessment.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24017358
• Report Number: 9612169-2026-00072
• Device Sequence Number: 13407633
• Product Code: HQL
• UDI-Device Identifier: 00380658490300
• UDI-Public: (01)00380658490300(17)300202(11)250204(10)25990797
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026

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: PXCAT0
• Device Catalogue Number: PXCAT0.180
• Device Lot Number: 25990797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/11/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/06/2026; 04/06/2026
• Date Device Manufactured: 02/04/2025
• 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: CLAREON MONARCH IV IOL, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown