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	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	11/03/2025
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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the lens was exchanged for another lens model 03 months 11 days following the initial procedure.Clinical reason for explant was mentioned as halos and light sensitivity.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in a.2., a.3.A., b.5., b.6 and d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that the patient was never really happy with vision post-operative.In surgeon's opinion product was contributed to the event and prognosis was good.
Additional Manufacturer Narrative
Additional information was provided in b.3., b.5., b.6., b.7 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, patient experienced decreased distance vison, ghost images at near and glare.There are two medical device reports associated with this patient.This report is associated with the left eye.

• 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: 24333371
• Report Number: 9612169-2026-00335
• Device Sequence Number: 9744941
• Product Code: MJP
• UDI-Device Identifier: 00380658491437
• UDI-Public: (01)00380658491437(17)300801(11)250803(10)26089791
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: PXCAT3.255
• Device Lot Number: 26089791
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 03/12/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/09/2026; 04/03/2026
• Date Device Manufactured: 08/03/2025
• 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: ORA SYSTEM WITH VERIFEYE MESSAGING.; PROVISC OPHTHALMIC VISCO SURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male