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

Model Number CNA0T0

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

A physician reported that during implantation of an intraocular lens (iol) the speed control of the delivery system was not pressed with patient contact.Additional information was 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 could not be confirmed.The device was returned in the blister tray inside the carton.The lock-out assembly has been removed.The plunger is oriented correctly.Viscoelastic is dried in the device.The lens is advanced at the pause location.The plunger position is acceptable.The trailing haptic is folded onto the optic.The plunger is in contact with the trailing optic edge.The leading haptic is extended straight and is looped.The customer report cannot be confirmed.The product investigation could not identify the root cause for the reported complaint "the speed control of the company was not pressed".The device was received activated with the lens advanced at the pause location.The customer has specified that the lens was not moving forward after pressing the lever.The received sample does not match the reported description.The plunger and the lens was advanced at the pause location.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
• 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: 16012783
• MDR Text Key: 306205898
• Report Number: 9612169-2022-00702
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 25290410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1