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

Model Number	CNA0T0
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2025
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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, when doctor deployed the lens it came folded weird and was not usable.There was patient contact.The procedure was completed on same day.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and the reported complaint could not be observed.Iol (intraocular lens) was not returned.Only the device was returned.The device was received loose in a plastic bag.The lock-out assembly has been removed.Viscoelastic and what appears to be blood is observed in the device.The plunger has been advanced at the depth guard.No damage observed.Iol was not returned.The product investigation could not identify the root cause for the reported complaint "when doctor deployed the lens it came folded weird" as the lens was not returned.Only the device was returned for evaluation.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 22750533
• Report Number: 9612169-2025-01605
• Device Sequence Number: 18528567
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: (01)00380652396479(17)270403(11)240404(10)25832472
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: CNA0T0
• Device Lot Number: 25832472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown