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

Model Number CNA0T0

Device Problems Unintended Ejection (1234); Failure to Advance (2524)

Patient Problem Eye Injury (1845)

Event Date 10/12/2022

Event Type  Injury  

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).

Event Description

A health care professional reported that during the cataract surgery with intraocular lens (iol) implant procedure lens was being injected into the eye but for some reason it got stuck in the wound.The iol started to unfold before the surgeon had a chance to put it in place.The surgeon had to increase the wound size slightly and removed the lens.Another lens was opened and used with no issues.

Manufacturer Narrative

Correction: on initial mdr the product code of 2524 was erroneously sent.The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in a clear, plastic bag in the carton.The lock-out assembly has been removed.The plunger is oriented correctly.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.The lens is returned in the clear plastic bag.Solution is observed on the iol.No damage observed.We are unable to determine the root cause for the reported complaint "lens stuck in wound and start to unfold".No damage was observed to the returned device or iol.The instruction for use (ifu) instructs: "insert the nozzle tip into the incision as far as needed to facilitate lens implantation, using the depth guard as the insertion limit, and aim the nozzle tip at the anterior capsule opening.Maintain adequate pressure to ensure the nozzle tip remains in the incision¿.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: 15813487
• MDR Text Key: 303798522
• Report Number: 9612169-2022-00620
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393775
• UDI-Public: 00380652393775
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25326785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention