MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System; Lens, Intraocular, Toric Optics

Model Number	CNA0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an intraocular lens implant procedure dirt was noticed (adherence) when implanting.An attempt was made to remove the adherent material during surgery, but as it could not be removed.Upon reviewing the footage of the positioning step, a deposit or scratch-like mark is visible before the plunger advances the lens.The lens was exchanged during the initial procedure and replaced with unspecified lens.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System
• 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: 50852203
• Report Number: 9612169-2026-02132
• Device Sequence Number: 10025735
• Product Code: MJP
• UDI-Device Identifier: 00380652398800
• UDI-Public: (01)00380652398800(17)290624(11)250626(10)26062094
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: CNA0T3
• Device Lot Number: 26062094
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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
• Patient Sex: Unknown