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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the lens got scratched.Advanced in delivery system plunger went between two haptics.Product was good, advancing failed which caused the issue of position to compromise lens.Additional information was requested and received stating that the lens was opened by the circulator nurse after verification with the doctor.The lens contacted a non-company ovd and was noted to be preloaded midway in the company cartridge.The lens was handled by the scrub technician using non-company forceps, and the lens was lifted by the haptic with forceps and then folded with sterile gloves using forceps to place the lens into the cartridge.The lens was advanced further into the cartridge with forceps, with the forceps tips closed and positioned towards the walls of the cartridge during the process to safely advance the lens, and it was then advanced further with the injector or handpiece to complete the process.The doctor advised the technician to ensure that the injector or handpiece did not pass between the haptics and the lens during advancement, as this was reported to be the reason the lens became scratched.

• 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 ; 8007579780
• MDR Report Key: 25270746
• Report Number: 1119421-2026-01114
• Device Sequence Number: 9205816
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: (01)00380659777639(17)290111(11)260113(10)16189501
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/19/2026

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: 16189501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 01/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC PLUS 1.6% LOT#031544; CLAREON TORIC UV ABSORBING IOL; MCPHERSON'S FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown