MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The used monarch iii (d) cartridge was returned.Inadequate viscoelastic was observed in the cartridge.No cartridge damage was observed.The cartridge had evidence of placement into a handpiece.The cartridge tip was direct measured.The tip dimension met specification.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.It cannot be determined if the lens was qualified as the diopter was not provided.A qualified viscoelastic was indicated with a monarch iii handpiece.The qualified handpiece for clareon lenses is the monarch iv handpiece.No problem was found.The cartridge tip met specification.Monarch cartridge manufacturing is a validated operation, with specifications that are maintained and documented.No supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.Inadequate viscoelastic was observed.The ifu instructs: completely fill the cartridge with ovd prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.It cannot be determined if the lens was qualified as the diopter was not provided.The qualified handpiece for clareon lenses is the monarch iv handpiece.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that the cartridge did not enter the wound after incision with a 2.4 mm knife during insertion.The surgery was performed and completed after replacing the cartridge with another one.There was no patient harm.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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: 16689509
• MDR Text Key: 312778928
• Report Number: 1119421-2023-00604
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063155
• 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
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE