MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number CNWTT0

Device Problems Break (1069); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during insertion of the intraocular lens (iol), during an implant procedure, the lens got stuck in clarion injector and haptic broke off.There was patient contact.The procedure was completed on same day.Additional information has been requested.

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).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18977591
• MDR Text Key: 338576769
• Report Number: 1119421-2024-00559
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 00380652408202
• UDI-Public: 00380652408202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.240
• Device Lot Number: 15269932
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; DUOVISC VISCOELASTIC SYSTEM.