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 Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that, during intraocular lens implantation surgery, the lens would not advance.There was patient contact and the procedure was completed on the same day.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be observed.Iol was returned outside of the device.The device was returned in the blister tray in the carton.The lock-out assembly has been removed.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.Iol returned in the blister tray.Viscoelastic is dried in the iol.No damage observed.The product investigation could not identify the root cause for the reported complaint "would not advance" as the lens was returned outside of the device, the plunger was fully advanced.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.No damage was observed to the lens or to the device.The reported complaint is lacking in relevant information such as viscoelastic used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.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: 17973429
• Report Number: 9612169-2023-00732
• Device Sequence Number: 5118938
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: 00380652396479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/23/2024

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 Expiration Date: 09/08/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25262948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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