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

Catalog Number	8065977762
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, crack was observed at the tip of the cartridge and there was no patient harm.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL Delivery System, Cartridge C
• 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: 50893444
• Report Number: 1119421-2026-01940
• Device Sequence Number: 20333928
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: (01)00380659777622(17)280917(11)250919(10)16124710
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 8065977762
• Device Lot Number: 16124710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 09/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION Vision System
• Patient Sex: Male