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

Model Number	PXCWT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	05/12/2025
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 patient inability to drive at night and trouble reading.The iol was exchanged for unspecified lens model 2 months and 16 days after the initial implant procedure.Clinical reason for explant was reported as visual discomfort.Additional information has been requested.
Event or Problem Description
Additional information has been received and stated that events affect ability to drive at night and trouble reading, visual discomfort, patient states: "she cannot read at all at the computer or when reading a book.
Additional Manufacturer Narrative
Additional information was provided in a.2., b.5., b.6., b.7.And h.11.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.The reporter stated the company 195 diopter iol (intraocular lens) was replaced with a company 220 diopter iol.An iol exchange for a difference equal to or greater than two diopters indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The company 19.5 diopter lens was exchanged to a company 22.0 diopter lens.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 TORIC TRIFOCAL UV ABSORBING IOL
• 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: 24144696
• Report Number: 9612169-2026-00166
• Device Sequence Number: 9210838
• Product Code: MJP
• UDI-Device Identifier: 00380658434465
• UDI-Public: (01)00380658434465(17)290821(11)240823(10)25895297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/17/2026

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: PXCWT4
• Device Catalogue Number: PXCWT4.195
• Device Lot Number: 25895297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/23/2026; 03/26/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026; 04/17/2026
• Date Device Manufactured: 08/23/2024
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female