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	11/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 had fuzzy vision, glare and halos.The iol was exchanged for another company same diopter lens.Clinical reason for explant mentioned as iol complication.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in a.2., b.3., b.5., b.6., b.7.And d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the patient had clear vision without halos post explant.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Iol was received cut in a half attached to a card inside a plastic bag.Solution is dried on the iol.The root cause for the reported complaint could not be determined.According to the instructions for use (ifu), some visual effects may be expected due to the superposition of focused and unfocused multiple images.These may include some perception of halos, radial lines around point sources of light (starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal iols, these visual disturbances may be significant enough in some cases that the patient may request explantation of the lens.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: 24019496
• Report Number: 9612169-2026-00083
• Device Sequence Number: 10590937
• Product Code: HQL
• UDI-Device Identifier: 00380658490140
• UDI-Public: (01)00380658490140(17)300408(11)250410(10)26025976
• 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): 04/17/2026

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: PXCAT0.100
• Device Lot Number: 26025976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/26/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/04/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; SINGULAIR (MONTELUKAST) 10 MG TABLET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown