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	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, the injector shaft got under the optical part of the lens.Additional information was requested, but no further information is available.
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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in clear plastic bag in the carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The lens bay doors are opened.The lens is positioned posterior surface up in the lens bay and is partially exiting the door.The plunger is advanced into the lens bay.The product investigation could not identify the root cause for the reported complaint "injector shaft got under optical part of the lens during implantation".The device was returned with the lens bay door opened and the lens has evidence of being removed from the device.Due to this, we are unable to confirm the lens position in the device 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: 18684048
• Report Number: 9612169-2024-00107
• Device Sequence Number: 6380425
• Product Code: HQL
• UDI-Device Identifier: 00380652393652
• UDI-Public: 00380652393652
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 05/01/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25629651
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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
• Patient Sex: Unknown