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

Model Number	CNWTT5
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2026
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 healthcare professional stated that during intraocular lens (iol) implantation, surgeon found that lens was scratched after the surgery.Surgeon confirmed that during lens implantation, the forceps was not touch with optic and no mark on the lens before implantation.The surgery was completed on the same day.Additional information has been received that patient did not observe any deterioration.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Received photo shows what appears to be an implanted iol, there seem to be marks on the iol.Based on our observation of the attached photo, there seem to be marks on the implanted iol.The origin of the observed marks cannot be confirmed based on the returned photo alone and without evaluating the physical product.The product was subject to handling and the reported complaint was highlighted post implantation.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24401459
• Report Number: 9612169-2026-00407
• Device Sequence Number: 8224089
• Product Code: MJP
• UDI-Device Identifier: 00380652469654
• UDI-Public: (01)00380652469654(17)281013(11)241015(10)25935052
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: CNWTT5
• Device Catalogue Number: CNWTT5.230
• Device Lot Number: 25935052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 10/15/2024
• 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: MONARCH III IOL, CARTRIDGE D; VISCOAT OVD
• Patient Sex: Female