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

Model Number	CNWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Insufficient Information (4580)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, the iol was exchanged.Additional information has been requested.
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of serial number of the product.G.8.Manufacturer report number corrected and reported under 9612169-2025-02432 the manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, patient experienced refractive surprise with astigmatism and under correction despite of perfect positioning.After further discussion, it turns out the doctor simply made an incorrect calculation or estimation.So, there was nothing wrong with the company lens.The lens still remains in the patient eye and was planned to be explanted.Additional information was received and stated, after 6 weeks of initial procedure the lens was explanted and replaced with another lens on (b)(6) 2025.The symptoms were resolved and there was no residual astigmatism.

• 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 WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23390857
• Report Number: 1119421-2025-02790
• Device Sequence Number: 10038803
• Product Code: MJP
• UDI-Device Identifier: 00380652468923
• UDI-Public: (01)00380652468923(17)270110(11)230112(10)25567385
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.130
• Device Lot Number: 25567385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 01/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male