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	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.The lens remains implanted.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 during an intraocular lens (iol) implant procedure, the iol had a dark mark on the lens.It was left in the patient eye as the surgeon decided it was not going to affect vision.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Photo review: provided photo shows an implanted iol on a screen.There is a dark mark on the periphery of the optic of the lens (@ 4 o¿clock).The exact location of the mark (anterior or posterior surface of the optic) cannot be confirmed from the returned photo.Based on our observation of the attached photo, there appears to be a dark mark on the periphery of the optic.The origin of the observed mark cannot be confirmed based on the returned photo alone and without evaluating the physical product.A final root cause cannot be determined based on available information.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: 23094401
• Report Number: 9612169-2025-01862
• Device Sequence Number: 18517483
• Product Code: MJP
• UDI-Device Identifier: 00380658491314
• UDI-Public: (01)00380658491314(17)300310(11)250312(10)25988123
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXCAT3
• Device Catalogue Number: PXCAT3.195
• Device Lot Number: 25988123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 03/12/2025
• 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
• Patient Sex: Unknown