MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Toric IOL; Lens, Intraocular, Toric Optics

Model Number	CNW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported that, during an intraocular lens (iol) implantation procedure, no shooter damage was observed, no challenges were encountered during iol loading or implantation, and the irrigation/aspiration (i/a) handpiece did not contact the optic; however, following implantation, a dent was observed on the optic.Additional information was received that the lens remained implanted in the patient's eye, as only one week had elapsed since implantation and a thorough evaluation had not yet been performed.It was further reported that the patient had not experienced any issues.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains 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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50470802
• Report Number: 9612169-2026-01946
• Device Sequence Number: 13304985
• Product Code: MJP
• UDI-Device Identifier: 00380652402309
• UDI-Public: (01)00380652402309(17)290810(11)250812(10)26086337
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 26086337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/02/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 08/12/2025
• 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: Epsilon shooter; VISCOAT Ophthalmic ViscoSurgical Device
• Patient Sex: Unknown