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

Model Number CNA0T0

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A non-health care professional reported during the intraocular lens implantation the leading haptic was aiming right in a patient with a small pupil.The patient was on flomax.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).

• 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: 15803503
• MDR Text Key: 303702277
• Report Number: 9612169-2022-00616
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393638
• UDI-Public: 00380652393638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25388334
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention