MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)

Model Number	IV
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, the lens was inserted into the eye with the injector set as usual, and the iol was confirmed to be damaged.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
• Common Device Name: FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24955523
• Report Number: 2523835-2026-00419
• Device Sequence Number: 17453351
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: (01)00380659777745(17)310831(11)210805(10)141D9N
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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 Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: 141D9N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/22/2026
• Date Device Manufactured: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON TORIC IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown