MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	PXYWT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that, after intraocular lens implantation surgery, the patient experienced severe halos od (right eye) which are causing her to be homebound because she can't drive.The subject returned on (b)(6) 2025 still complaining of visual disturbance patient returned again and still complaining of visual disturbance.So, they have planned for explant.
Additional Manufacturer Narrative
The product 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
Additional information has been requested and received stating that the patient had the right eye exchange on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information has been provided in b.2., b.5., h.3., and h.6.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 22149606
• Report Number: 9612169-2025-01180
• Device Sequence Number: 15416348
• Product Code: MFK
• UDI-Device Identifier: 00380658411008
• UDI-Public: (01)00380658411008(17)290120(11)240123(10)25779307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: PXYWT0
• Device Catalogue Number: PXYWT0.170
• Device Lot Number: 25779307
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown