MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	01/31/2025
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).
Event or Problem Description
A nurse reported that during surgery noticed the tears where in multiple locations, from haptic to lens, it was removed in a secondary implant procedure.Additional information has received and it states that issue was noted during the insertion of the lens through the injector after preparation.Lens removed during initial procedure, then destroyed and back up lens inserted.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC 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: 21513337
• Report Number: 9612169-2025-00317
• Device Sequence Number: 20834955
• Product Code: MFK
• UDI-Device Identifier: 00380652408127
• UDI-Public: (01)00380652408127(17)260518(11)220520(10)25415333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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 Expiration Date: 05/18/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.200
• Device Lot Number: 25415333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 05/20/2022
• 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: DUOVISC VISCOELASTIC SYSTEM
• Patient Sex: Unknown