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

Model Number CNA0T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported following the intraocular lens implantation the patient had experienced white biological deposit on the lens, lecog like with variable intensity, sometime requiring a yag anterior capsulotomy.Additional information has been requested.

Manufacturer Narrative

The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned for analysis.Only five photos were returned.Photos 3, 4 and 5 appear to be of the same eye under various magnifications.A cellular deposit, possibly fibrotic in nature, is present on the anterior surface of the lens expanding inward from the periphery and joining to form a bridge across the pupillary zone.Photos 1 and 2 appear to be of the same eye (unknown if the same as in images 3-5) possibly showing the eye post-yag demonstrating a retraction of the cellular material as conveyed in the follow up information provided.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received and stated that, the eye that had a deposit in the pupillary axis is doing really well since its yag (yttrium aluminum garnet) laser.Post operation with reduced visual acuity ad 20/50 and after yag there is no more deposit and patients vision is back to 20/20.The symptoms were resolved to the patient.

• 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: 13087972
• MDR Text Key: 282778445
• Report Number: 9612169-2021-00310
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393713
• UDI-Public: 00380652393713
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: CNA0T0
• Device Lot Number: 21277928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention