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

Model Number CNA0T0

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The product was 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.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 a cataract extraction with an intraocular lens (iol) implant procedure, insertion failure of the iol was occurred during insertion.The surgery was completed after replacing the product with another one.Incision size was 2.4mm.Additional information was requested, but further no information was available.

Manufacturer Narrative

The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in a blister tray in the carton.The lock out assembly have been removed.Insufficient ovd (ophthalmic viscosurgical devices) observed in the device - no ovd (ophthalmic viscosurgical devices) past the lens.The plunger and the lens are advanced into the mid nozzle.The plunger is at the trailing optic edge.The haptics are folded onto the optic.Reported complaint cannot be confirmed.No root cause identified as the reported complaint "insertion failure occurred" could not be confirmed.The company device was returned with the lens advanced into the mid nozzle.The position of the lens and the plunger is correct.Inadequate viscoelastic was observed in the device.No ovd (ophthalmic viscosurgical devices) was observed past the lens.The ifu (instructions for use) instructs: fill the device until ovd (ophthalmic viscosurgical devices) can be observed flowing to the nozzle tip, then retract the cannula.This will require approximately 0.28 ml of ovd (ophthalmic viscosurgical devices).Based on the results from the product history record, the products met release criteria.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: 16493813
• MDR Text Key: 310778817
• Report Number: 9612169-2023-00186
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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: 25424315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC.