MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon PanOptix Trifocal Hydrophobic Intraocular Lens; Lens, Multifocal Intraocular

Model Number	CNWTT0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: Clareon PanOptix Trifocal Hydrophobic Intraocular Lens
• Common Device Name: Lens, Multifocal Intraocular
• Manufacturer (Section D): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50747087
• Report Number: 1119421-2026-01863
• Device Sequence Number: 15992352
• Product Code: MFK
• UDI-Device Identifier: 00380652408158
• UDI-Public: (01)00380652408158(17)290701(11)250703(10)16071758
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.215
• Device Lot Number: 16071758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/13/2026
• Date Device Manufactured: 07/03/2025
• 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
• Patient Sex: Unknown