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	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction information provided in h.6.On initial mdr submitted, the product code should have been a150205 instead of a140504.Additional information provided in d.9.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 ; +1(800)757-9780
• MDR Report Key: 50114552
• Report Number: 2523835-2026-00802
• Device Sequence Number: 14778585
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: (01)00380659777738(17)350531(11)250630(10)17HRDL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 17HRDL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 06/30/2025
• 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
• Patient Sex: Unknown