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

Model Number CNA0T0

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 11/21/2022

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 physician reported that during intraocular lens (iol) implantation, found one haptic is broken in the sterile pack.The patient was left aphakic on that time and lens was implanted after few days.

Manufacturer Narrative

Additional information was provided in d.9., h.3., h.6.And h.10.The sample is returned for evaluation.Investigation is in progress.Photo shows fully activated preloaded device.The lens is placed over the device.One haptic is broken/torn.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 returned loose inside the carton.The lockout assembly has been removed.The plunger has been fully advanced outside the tip of the nozzle.Viscoelastic is dried in the device.Stress and aneurysm observed on the nozzle tip.Iol was returned outside of the device attached to the device with a clear tape.Viscoelastic is dried on the iol.One haptic is broken/torn and not returned.We are unable to determine the root cause for the reported complaint "one haptic is broken in the sterile pack".The device was returned with the plunger fully advanced and the lens outside of the device.Damage was observed to the tip of the nozzle.The observed damage typically occurs if there is a lack of viscoelastic between the lens and the cartridge lumen and/or if the plunger is not positioned correctly at the trailing optic edge for advancement.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle causing damage or become stuck.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: 16041508
• MDR Text Key: 306065119
• Report Number: 9612169-2022-00716
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25298574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male