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

Model Number	CNWTT0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
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 during surgery lens was defective in the packaging, but we did not notice it until the implantation stage.The surgeon only detected the issue when the lens was already in the patient's eye.As a result, we had to remove it from the patient¿s eye by splitting and extracted the lens and then implanted a new corresponding one during the initial procedure.Additional information has received and it stated that the leading haptic bulge on the edge of the lens and it was inside the eye and the doctor saw what lens was defective.The doctor decided to cut the lens and pull out.We had another lens in the hospital was used.It was little bit longer than usual.

• 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: 21445400
• Report Number: 9612169-2025-00252
• Device Sequence Number: 7320719
• Product Code: MFK
• UDI-Device Identifier: 00380652408134
• UDI-Public: (01)00380652408134(17)260208(11)220210(10)25333382
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/24/2025

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: 02/08/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.205
• Device Lot Number: 25333382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 02/10/2022
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Patient Age: 61 YR
• Patient Sex: Male