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

Catalog Number 8065977762

Device Problem Defective Device (2588)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

A healthcare professional reported with a description of loading area of the cartridge was small, making it difficult for forceps to push in, and the tip was small, making it difficult for intraocular lens (iol) to be injected.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One unused company cartridges was returned in the opened pouch.The unused company cartridge was microscopically examined with no damage or abnormalities observed.The loading area and the cartridge tip were measured and verified to meet specifications.The associated products were not provided.It is unknown if qualified associated products were used.No problem was found with the returned unused company cartridge.The cartridge was measured and verified to meet specifications.Cartridge manufacturing is a validated operation, with specifications that are maintained and documented.No changes have been made for the manufacturing of cartridges.Supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.It is unknown if qualified associated products were used.The ifu instructs: company foldable iols are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 18148555
• MDR Text Key: 328282266
• Report Number: 1119421-2023-01911
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112977
• 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: 01/09/2024

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: 8065977762
• Device Lot Number: 15617227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1