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 Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implantation procedure, the cartridge did not stay seated and locked into place during advancement of the lens into the patient's eye.The lock was expected to snap into place, but it did not.The surgeon noted that the patient had a very shallow amount of depth for reinsertion of the lens.The cartridge did not allow the product to advance properly and was very stiff.During lens insertion, an audible click was heard, and the cartridge backed out slightly from the plunger.Additional information was requested but was not 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: 50195025
• Report Number: 1119421-2026-01668
• Device Sequence Number: 15924577
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: (01)00380659777639(17)290517(11)260519(10)16266886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 16266886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 05/19/2026
• 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