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 Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, could not use due to foot pedal failure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that plunger bypassed the iol and it was not able to be discharged from the cartridge.
Additional Manufacturer Narrative
The product was returned for analysis, and the reported complaint was not observed.The product was not returned in the reported condition.The device is returned loose in the carton.The lock out assembly is present on the device.There is no ophthalmic viscosurgical devices (ovd) applied in the cartridge and the lens is present in the lens bay.The device has not been used.The plunger is moving freely.The device is activated for testing purpose.The gas canister is punctured and moved plunger forward and stops as intended.The reported complaint is not observed.The root cause for the reported complaint "plunger bypassed the intraocular lens (iol) and it was not able to be discharged from the cartridge" could not be determined.The product was not returned in the reported condition.No clarification was received from the reporter.The product was received inactivated, the lens 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: 24275082
• Report Number: 9612169-2026-00254
• Device Sequence Number: 10722810
• Product Code: HQL
• UDI-Device Identifier: 00380652393720
• UDI-Public: (01)00380652393720(17)280409(11)250411(10)26015387
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/28/2026

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: CNA0T0
• Device Lot Number: 26015387
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 04/02/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/10/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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