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

Model Number	CNA0T5
Medical Device Problem Codes	Failure to Deliver (2338); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint was observed.The device was returned loose inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The lens is present in the lens bay.The lever is moving freely and the plunger is not advancing.The device is taken apart for further evaluation.The canister is fully punctured.Lubricant is observed on the canister neck.No damage observed to o-rings.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated; the device activated with no issues.The root cause for the reported complaint is deemed to be manufacturing related (the faulty sub-assembly is supplied by company's vendor in (b)(6)).The product did not meet specifications.The plunger is not advancing when the lever is pressed.Based on the results from company manufacturing batch record, the products met release criteria.Investigation has been completed based on current information.The vendor has been notified of this complaint (see attached email).Based on our trend analysis there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.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: 50085270
• Report Number: 9612169-2026-01730
• Device Sequence Number: 13219851
• Product Code: MJP
• UDI-Device Identifier: 00380652399913
• UDI-Public: (01)00380652399913(17)290310(11)250312(10)26003459
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: CNA0T5
• Device Lot Number: 26003459
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown