MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
A healthcare professional reported with a description of faulty intraocular lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been received and indicated that the shooter was not engaging with lens while loading with no patient contact.Based on this information this event no longer meets incident and reporting criteria per applicable regulation, because there is no indication of deterioration in the characteristics or performance of a device, use-error related to ergonomic design or any undesirable side-effect.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that, the problem was with the shooter.The shooter was not engaging with lens while loading.There was no patient contact.

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 23463862
• Report Number: 9612169-2025-02198
• Device Sequence Number: 13018787
• Product Code: HQL
• UDI-Device Identifier: 00380652396493
• UDI-Public: (01)00380652396493(17)260329(11)230331(10)25619259
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25619259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 03/31/2023
• 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: DUOVISC OVD.
• Patient Sex: Unknown