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

Model Number CNA0T0

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.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 following an intraocular lens (iol) implant procedure, discovered a bronze-like imprint on the implanted lens.Additional information was requested and received.

Event Description

Additional information was requested and received.The lens was later exchanges in a secondary procedure.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.Iol returned in two segments in a specimen container.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is torn/split-cut and scratched/marked-rejectable.There is a streak of a bronze-like colour observed on the optic area within the solution.The lens is cleaned for further evaluation.It is confirmed that the observed streak was not a part of the lens material but was present within the solution.The origin of the bronze-like streak is unknown.Test for the presence of silicone oil was performed, no silicone oil detected on the lens.Company device was not returned.The product investigation could not identify the root cause for the reported complaint "bronze-like imprint on the implanted lens".During the product evaluation, it was confirmed that the observed "bronze-like" colour was present within the solution and not in the lens material.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: 13620835
• MDR Text Key: 286427271
• Report Number: 9612169-2022-00090
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393706
• UDI-Public: 00380652393706
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 06/06/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25253516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 05/09/2022
• Supplement Dates FDA Received: 04/08/2022; 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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 Age: 81 YR
• Patient Sex: Female