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

Catalog Number	8065977758
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event report for this file was received from the brazilian health authority reporting with a description of company cartridge apparently flattened and cannot be used (intraocular lens does not fit).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.If the tip is inadvertently pressed against a hard surface or pressure is inadvertently applied to the tip surface, the tip could be damaged.All company cartridges are 100 percentage inspected for cosmetic attributes and tip damage would not have met company release criteria.Procedures and processes exist within the manufacturing environment that focus on protection of the cartridge tip.The obvious nature of the damage and the extreme pressure needed to create it makes it unlikely that product would have left the company facility in this condition.No further information can be obtained for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22715028
• Report Number: 1119421-2025-02141
• Device Sequence Number: 15860068
• Product Code: MSS
• UDI-Device Identifier: 00380659777585
• UDI-Public: (01)00380659777585(17)270228(11)240301(10)15820859
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K001157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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
• Operator of Device: Other
• Device Catalogue Number: 8065977758
• Device Lot Number: 15820859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 03/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown