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

Model Number	PXCAT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2025
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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was unhappy with the quality of vision despite good objective snellen visual acuity, with intraoperative floppy iris syndrome (ifis) causing iris atrophy and photophobia though he functioned outdoors with sunglasses, and shading temporal light made no difference; there was no significant refractive error, optical path difference (opd) scan showed a normal corneal surface, and optical coherence tomography (oct) showed no retinal edema, he was not expected to be happy with a multifocal iol (miol).In the future an iol xc was recommended and it was discussed that this would be a delicate procedure to try to avoid further iris damage, with photophobia to be reassessed afterward and iris sutures considered if it affected functioning; the lens was exchanged for another lens model 4 months and 11 days following the initial procedure.In surgeon's opinion product was not contributed to the event but it was patient dissatisfaction.There was no further harm to the patient.Additional information has been requested.
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 received adhered to card.The iol has been split cut into 3 pieces.The optic has fibers and particulate.The reporter states the company iol was replaced with a monofocal iol.The root cause for the reported complaint could not be determined.The reported exchange of a multifocal lens for a monofocal lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.The instructions for use (ifu) states that 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 ils, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal iol.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 TORIC UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24172927
• Report Number: 9612169-2026-00182
• Device Sequence Number: 13154100
• Product Code: MJP
• UDI-Device Identifier: 00380658491314
• UDI-Public: (01)00380658491314(17)300202(11)250204(10)25984983
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 04/16/2026

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: PXCAT3
• Device Catalogue Number: PXCAT3.195
• Device Lot Number: 25984983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DUOVISC VISCOELASTIC SYSTEM.; ORA SYSTEM WITH VERIFEYE MESSAGING, CART.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male