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

Model Number	CNW0T4
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis, the lens remain implanted.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 physician reported that the problem was the iol coating.On the first operative day one, the lens seemed blue at a medical examination.The lens remained in the patient's eye.Additional information has been received stating that, as of one week after the surgery, the lens finding was still continuing.
Additional Manufacturer Narrative
Additional information was provided in e.11 and h.11.The product was not returned for analysis.Only photos were returned.Received photo shows what appears to be an implanted intraocular lens (iol) on a monitor screen.There appears to be a blue cloudy effect over the iol, there are also lines through the cloudiness.These photos are marked with '1/10', this marking seems to correspond with the dates mentioned throughout the complaint.Additional photos received show what appears to be an implanted iol on a monitor screen.There appears to be a blue cloudy effect over the iol, there are also lines through the cloudiness.These photos are marked with 1/16 , this marking seems to correspond with the dates mentioned throughout the complaint.The origin of the reported complaint cannot be confirmed.Complaints have been received reporting a potential presence of 'polychromatic sheen'.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 21312618
• Report Number: 9612169-2025-00155
• Device Sequence Number: 8903853
• Product Code: MJP
• UDI-Device Identifier: 00380652410199
• UDI-Public: (01)00380652410199(17)270705(11)230707(10)25677093
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Model Number: CNW0T4
• Device Lot Number: 25677093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 07/07/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Female