MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A physician reported that during a cataract surgery with intraocular lens (iol) implant procedure, the physician noticed a scratch on the implant.The scratch was observed during deployment into the capsular bag.There was no patient impact.Additional information has been requested.

• 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 ; 8007579780
• MDR Report Key: 23850672
• Report Number: 1119421-2025-03199
• Device Sequence Number: 21193519
• Product Code: MFK
• UDI-Device Identifier: 00380652408219
• UDI-Public: (01)00380652408219(17)280409(11)240411(10)15839275
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: CNWTT0.245
• Device Lot Number: 15839275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 04/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV IOL DELIVERY SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown