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	Visual Disturbances (2140)
Date of Event	04/28/2025
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 physician reported that following an intraocular lens (iol) implantation procedure involving a toric lens, a plaque-like film was observed on the lens surface.Prior to loading the lens into the cartridge, no abnormalities were noted.The implantation itself proceeded without complications.A viscoelastic from another company was used during the procedure.Two hours post-surgery, a slit-lamp examination revealed an iridescent glare on the lens surface, resembling petrol slicks on water.The glare has become more brighter.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 photos and video were returned.Received photos & videos show an implanted iol.A light is passed over the eye.A blue/green cloudy appearance can be seen on when the light passes over the pupil.It was reported that the additional photos and video were recorded one week post operation.Received photos & videos show an implanted iol.A light is passed over the eye.A blue/green cloudy appearance can be seen on when the light passes over the pupil.The origin of the reported complaint cannot be confirmed.Complaints have been received reporting a potential presence of 'polychromatic sheen.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: 22094797
• Report Number: 9612169-2025-01135
• Device Sequence Number: 20848023
• Product Code: MJP
• UDI-Device Identifier: 00380652409650
• UDI-Public: (01)00380652409650(17)280217(11)240219(10)25804554
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 07/09/2025

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: 25804554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 02/19/2024
• 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: METHYLCELLULOSE OVD.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PISTON INJECTOR.
• Patient Sex: Female