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

Model Number	CNA0T0
Medical Device Problem Codes	Defective Component (2292); Inaccurate Delivery (2339); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during the intraocular lens (iol) implant procedure, once the lever was pressed down on the preloaded delivery system, the lens kept advancing forward despite fingers being lifted off.There are three medical device reports associated with this complaint.This report is 1 of 3.Additional information has been requested however no further information available.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information provided in b.5., d9, h.3., h.6.And h.11.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information was received and stated based on the query raised.It stated that the returned sample showed a broken pin stop, which appeared to be a different issue than what was originally reported.The reporter was not sure whether this happened during the incident or afterward.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was returned for analysis and the reported complaint "lenses kept going forward despite fingers lifted off" was not observed.The product was not returned in the reported condition.Product carton was received with a note "no implanted, damaged".The device was returned in an opened blister tray.The lock-out assembly has been removed.The pin stop is broken and is stuck in the lens bay door in the pin stop designated area.Solution is dried in the device.The device was received activated.The lens is crushed around the broken pin stop and the plunger is advanced to between mid-nozzle and the depth guard.The returned sample was observed to have a different issue than reported.The customer reported several products under identical description.No clarification was received from the reporter.Product carton was received with a note "no implanted, damaged".On the evaluation of the product it was determined that the issue is related to a broken pin stop.The product did not meet specifications.The lens pin stop was found to be broken and stuck in the lens bay door in the pin stop designated area.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22726232
• Report Number: 9612169-2025-01558
• Device Sequence Number: 9143638
• Product Code: HQL
• UDI-Device Identifier: 00380652393614
• UDI-Public: (01)00380652393614(17)270129(11)240131(10)25783215
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 25783215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 11/19/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/14/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Patient Sex: Unknown