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

Model Number	CNW0T6
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported during intraocular lens (iol) implant procedure, the surgeon noticed that the optic was found cloudy partially.The surgery itself was completed without product replacement; the product remained in the patient's eye.The condition of the patient was observed.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information was provided in b.5.And h.11.The product was not returned for analysis.Only photos were returned.Photo review: received photo shows what appears to be an implanted intraocular lens (iol).The iol has a cloudy appearance.Additional photos show an implanted iol on a monitor screen, the iol appears cloudy, lines are also observed on the clouded iol.The origin of the reported complaint cannot be confirmed.Complaints have been received reporting a potential presence of polychromatic sheen.No harm to patients reported.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received, stating that the finding was observed right after the insertion of the iol during the surgery.The patient was satisfied with the postoperative condition.The surgeon did not mention details about the course of the finding.Additional information was received and confirmed to the sales representative that the finding had been continuing but there was no information after last follow up.

• 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: 20873352
• Report Number: 9612169-2024-01266
• Device Sequence Number: 18337004
• Product Code: MJP
• UDI-Device Identifier: 00380652411165
• UDI-Public: (01)00380652411165(17)280103(11)240105(10)25774357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: CNW0T6
• Device Lot Number: 25774357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 01/05/2024
• 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, CARTRIDGE D
• Patient Sex: Unknown