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

Model Number	PXCWT0
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.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 experienced poor contrast sensitivity.Clinical reason was diffractive iol.It was planned to replace with advanced technology intraocular lenses (atiol).Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in b.2 and d.4.Correction details have been provided in sections h.6 and h.11.The initial medical device report (mdr), the fda product code a0201 was submitted.It should have been a24, as the reported complaint description pertains to the nature of the lens (diffractive intraocular lens) and does not represent a device malfunction.Following further reassessment of all available information post-submission, it was determined that this event does not meet the criteria for reporting as a malfunction (previously reported).Additionally, the reported poor contrast sensitivity was not debilitating and did not impact the patient¿s ability to perform daily activities independently.Therefore, the event does not qualify as a serious injury per the reporting definition.No further reports are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING 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: 23555825
• Report Number: 9612169-2025-02282
• Device Sequence Number: 9764355
• Product Code: MFK
• UDI-Device Identifier: 00380658433000
• UDI-Public: (01)00380658433000(17)280331(11)250401(10)26007808
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXCWT0
• Device Catalogue Number: PXCWT0.220
• Device Lot Number: 26007808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 04/01/2025
• 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: REPLACEMENT ATIOL.
• Patient Sex: Unknown