MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number	III
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 physician reported that during an intraocular lens (iol) implant procedure the plunger could not be pulled out.Rotating the knob, the injector head did not move, and the iol could not be implanted.The surgery was completed on the same day.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., h.11.A sample was not received at the manufacturing site for evaluation for the report that the plunger could not be pulled out; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.While the root cause and its origin are inconclusive, the following factors outlined in the reported product¿s instruction for use (ifu) could potentially contribute to an outcome similar to the reported event.As part of handpiece preparation, users are advised to inspect the handpiece before each use for any damage.If the handpiece especially the plunger tip appears damaged, bent, or incapable of proper use, it must not be used and company contacted for support.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 22395761
• Report Number: 2523835-2025-00724
• Device Sequence Number: 20033500
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: (01)00380659777738(17)340131(11)240207(10)16J5JW
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 16J5JW
• 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: 06/08/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/26/2025
• Date Device Manufactured: 02/07/2024
• 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
• Patient Sex: Unknown