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

Model Number	CNWTT0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, the patient¿s preoperative vision with correction was 1.0 and following the intraocular lens (iol) implantation procedure the patient¿s visual acuity decreased to 0.7 and could not be improved with correction.Additionally, near vision was reduced to 0.4.The iol power calculations were verified as correct; however, the patient is not satisfied with the result.The physician suggested that the problem was in the iol, possibly a manufacturing defect.
Additional Manufacturer Narrative
The product was not returned for analysis.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.The root cause for the reported complaint could not be determined.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 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: 24774739
• Report Number: 9612169-2026-00740
• Device Sequence Number: 10036360
• Product Code: MFK
• UDI-Device Identifier: 00380652408066
• UDI-Public: (01)00380652408066(17)260615(11)220617(10)25432808
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 04/03/2026

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 Expiration Date: 06/15/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.170
• Device Lot Number: 25432808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 06/17/2022
• 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
• Patient Sex: Unknown