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	PXCAT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following intraocular lens implantation surgery, the patient was unhappy with halos and glare in both eyes, headaches, and blurred vision.As a result, the lens was explanted and replaced with a company lens (t4.160) lens in a secondary procedure.The clinical reason for explant was that the patient had declined vision correction procedures such as laser-assisted in situ keratomileusis (lasik) and photorefractive keratectomy (prk).The company lens (t4.160) was adjusted with a power of minus 1.00 to target more hyperopia.The surgery was completed without any harm to the patient.Additional information has been requested.There are two files associated with this report.This is 1 of 2.
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).
Additional Manufacturer Narrative
Correction information was provided in d.10.On the initial medical device report (mdr), the concomitant medical products (monarch iii iol delivery system, cartridge d, monarch iii iol delivery system, injector, and monarch ii loading forceps) were inadvertently added in d.10 section and submitted.These products should not have been reported on the initial report submitted.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: 23401149
• Report Number: 9612169-2025-02155
• Device Sequence Number: 10179900
• Product Code: MJP
• UDI-Device Identifier: 00380658491741
• UDI-Public: (01)00380658491741(17)300304(11)250306(10)25987986
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: PXCAT4
• Device Catalogue Number: PXCAT4.165
• Device Lot Number: 25987986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 03/06/2025
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female