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

Model Number	CNW0T3
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2026
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 physician reported that following an intraocular lens (iol) implant procedure, intraocular lens (iol) looked blue by the slit lamp.It was also stated that there was no subjective symptoms and visual acuity and no removal of lens was planned.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.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.Provided photo shows what appears to be an implanted iol (intraocular lens) on the screen.It appears that the lens is viewed through a slit lamp.The lens is looking blue.The observed condition is most likely polychromatic sheen.The root cause is deemed to be manufacturing related.Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.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 disappear over time following implantation.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 resolves once the iol is delivered and exposed to body temperature over time.There are no adverse impacts or lasting effects on the iol or the patient.Based on the results of the product investigation and testing, it was confirmed there are no adverse events or clinical impact on vision 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: 24684513
• Report Number: 9612169-2026-00654
• Device Sequence Number: 15884561
• Product Code: MJP
• UDI-Device Identifier: 00380652409704
• UDI-Public: (01)00380652409704(17)280416(11)240418(10)25835346
• 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): 05/22/2026

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: CNW0T3
• Device Lot Number: 25835346
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 04/18/2024
• 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 IOL INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown