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

Model Number CNA0T0

Device Problems Failure to Fold (1255); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

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 other health care professional reported that during an intraocular lens (iol) implant procedure, the intraocular lens pusher incorrectly positioned the lens in the narrow part of the cartridge, resulting in compression and detachment of the haptic element of the iol upon its exit from the device.The damaged iol was explanted and replaced with a similar one during initial procedure.There was no patient harm reported.Additional information has been requested.

Manufacturer Narrative

The product was not returned for analysis.Received photos shows an autonome device.The plunger is extended into the nozzle tip.One haptic is in the nozzle tip, it appears to be between the plunger tip and the nozzle wall.The remaining iol is outside of the device and has a mark/cut across the optic.Based on our observation of the attached photo, the haptic is broken.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 18524529
• MDR Text Key: 332980545
• Report Number: 9612169-2024-00063
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393768
• UDI-Public: 00380652393768
• Combination Product (y/n): N
• Reporter Country Code: BO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 25608748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 63 YR
• Patient Sex: Male