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	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that after intraocular lens (iol) implantation, the patient had blurry vision at all distances.The lens was removed and replaced with a monofocal lens in a secondary procedure.The clinical reason for explantation were, dysphotopsia, anisekonia, and anisometropia.According to the additional information received, the surgeon reported that the adverse events experienced by the patient were due to the iol.The lens exchange was done with a non-company lens in a secondary procedure.There was no further impact to the patient, and the surgeon confirmed that the patient is doing well.
Additional Manufacturer Narrative
Additional information provided in sections h.3., h.6., and h.11.The product was not returned for analysis.The reporter states the company intraocular lens (iol) was replaced with a monofocal iol.The root cause for the reported complaint could not be determined.The exchange to a monofocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.Based on the results from the product history record, the products met release criteria.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: 23553104
• Report Number: 9612169-2025-02275
• Device Sequence Number: 9775719
• Product Code: HQL
• UDI-Device Identifier: 00380658490348
• UDI-Public: (01)00380658490348(17)300329(11)250331(10)26008383
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: PXCAT0.200
• Device Lot Number: 26008383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 03/31/2025
• 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: AMVISC; ORA SYSTEM WITH VERIFEYE MESSAGING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female