MAUDE Adverse Event Report: Alcon Research, LLC - Huntington MONARCH III IOL Delivery System, Cartridge D; Folders and Injectors, Intraocular Lens (IOL)

Catalog Number	8065977763
Medical Device Problem Codes	Particulates (1451); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during an intraocular lens implantation surgery, while using the company lens with the cartridge, an imperfection was observed inside the cartridge.When the lens was injected, some material was introduced into the eye together with the lens.Additional information has been requested but no information is available at the time of this report.
Additional Manufacturer Narrative
A product 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).

• Brand Name: MONARCH III IOL Delivery System, Cartridge D
• 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 ; +1(800)757-9780
• MDR Report Key: 50223806
• Report Number: 1119421-2026-01692
• Device Sequence Number: 5482226
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: (01)00380659777639(17)290224(11)260226(10)16210669
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 8065977763
• Device Lot Number: 16210669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 02/26/2026
• 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