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

Model Number CNA0T0

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Visual Impairment (2138)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The root cause is deemed to be manufacturing related.Incorrectly labelled product was released.Internal investigation was raised as part of this investigation.Based on the results from the product history record, the products met release criteria.Investigation has been completed based on current information.There have been similar complaints for this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported following an intraocular lens implant procedure, the patient experienced considerable refractive errors.The lens seems to have been mislabeled.There are two medical device reports associated with this event.This is 1 of 2.Additional information has been requested.

• 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: 14786489
• MDR Text Key: 295801309
• Report Number: 9612169-2022-00291
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393805
• UDI-Public: 00380652393805
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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: 25273625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1