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

Model Number CNA0T0

Device Problems Defective Component (2292); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A physician reported during the intraocular lens (iol) implantation it was reported that the plunger could not be advanced even though the lever was pressed during insertion.The iol itself did not enter the patient's eye.The surgery was completed after replacing the product with another one of the same power.Additional information has been requested.

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.The device was received in a blister tray inside the carton.The lock-out assembly has been removed.Viscoelastic is dried in the device.The lens is present in the lens bay.What appears to be blood is dried on the tip of the nozzle.The lever is moving freely but the plunger is not advancing.The device is taken apart for further evaluation.The gas canister is fully punctured.Krytox is observed on the canister neck.No problem observed with the canister o-ring.No abnormalities observed.The device is reloaded with a new gas canister and activates with no issues.The root cause is deemed to be manufacturing related.The product did not meet specifications.The plunger is not advancing when the lever is pressed.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Type of Device: 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: 16171539
• MDR Text Key: 307939323
• Report Number: 9612169-2023-00054
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25356893
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1