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	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during an intraocular lens (iol) implantation procedure, the internal plunger used to advance the implant was not properly aligned, resulting in an injector malfunction.At the surgeon's request, another injector was provided so that the iol could be implanted, as the first injector could not be used for implantation.The operating room nurses were not in a position to determine the cause of the injector malfunction.The originally scheduled procedure was completed on same day with no patient impact.Additional information was requested but was 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: 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 ; +1(800)757-9780
• MDR Report Key: 50818237
• Report Number: 2523835-2026-00951
• Device Sequence Number: 10680328
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: (01)00380659777745(17)320731(11)220728(10)14XPDY
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212039
• 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): 09/18/2026

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: 14XPDY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/28/2022
• 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: AcrySof IOL
• Patient Sex: Unknown