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	01/29/2026
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 an issue that occurred during intraocular lens (iol) implantation procedure.When the lens was being injected into the eye, the loader became stuck, preventing proper advancement of the lens.They had to use another lens to complete the surgery.The reporter indicated that the loader was the main source of the problem.Additional information was received, providing further details about the reported event.The lens was halfway out of the cartridge during insertion; it touched the patient's eye but did not enter the eye because the loader was stuck.The surgery was completed on same day using a company lens of same model and diopter value as a replacement.There was no patient harm.According to the surgeon the event occurred due to loader malfunction, as it got stuck and did not advance correctly.The surgeon also noted that no other issues were observed during implantation, and there was no impact to either the nozzle or the iol.
Additional Manufacturer Narrative
Additional information provided in sections h.3., h.6., and h.11.A sample was not received at the manufacturing site for evaluation for the report that the injector got stuck; 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.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.The ifu states that the handpiece must be inspected prior to each use to confirm it is free of damage.It further emphasizes that if the handpiece¿particularly the plunger tip¿appears damaged, bent, or otherwise unfit for proper use, it must not be used.In such cases, users are instructed to contact the company immediately.The ifu also provides a list of qualified cartridge combinations to use.The use of an unqualified combination may cause damage to the intraocular lens (iol) and potential complication during the implantation process.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: 24469986
• Report Number: 2523835-2026-00205
• Device Sequence Number: 13165587
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: (01)00380659777738(17)350331(11)250410(10)17CM8T
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/29/2026

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: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 17CM8T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 04/10/2025
• 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 PANOPTIX TRIFOCAL HYDROPHOBIC IOL.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown