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

Model Number	CNW0T3
Medical Device Problem Codes	Material Opacification (1426); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 non-healthcare professional reported during an intraocular lens (iol) implant procedure, immediately after the lens implant, the optic surface was cloudy, and scratches appeared, so it was promptly explanted.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint is confirmed from the returned photo.Provided photo shows an implanted iol.There appears to be cloudiness/white marks and light reflections over the iol optic.The exact location of the marks ( anterior or posterior surface) cannot be confirmed from the returned photo.The reported cloudiness may potentially be related to polychromatic sheen.The root cause is deemed to be manufacturing related.The cause of ¿sheen¿ or ¿film-like¿ appearance is a result of a change in the positioning of the iol during the manufacturing process and is not associated with any foreign material or contamination.The observation has been reported clinically and confirmed in laboratory settings to rapidly disappear following implantation and should no longer be visible, or very little remaining, by the one-day postoperative visit.The appearance is a result of a temporary change in the surface of the iol that occurs during the delivery process which is only visible under certain orientations and illumination settings.This quickly resolves once the iol is delivered and exposed to intraocular temperature over time.There are no adverse impacts or lasting effects on the iol or the patient, and no adverse events or clinical impact on vision have been reported associated with this finding.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 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: 21881551
• Report Number: 9612169-2025-00660
• Device Sequence Number: 15428598
• Product Code: MJP
• UDI-Device Identifier: 00380652409728
• UDI-Public: (01)00380652409728(17)280415(11)240417(10)25835435
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/18/2025

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: CNW0T3
• Device Lot Number: 25835435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 04/17/2024
• 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: CLAREON MONARCH IV INJECTOR.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; DISCOVISC.; MONARCH III CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown