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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• 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 fwy; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50260164
• Report Number: 2523835-2026-00840
• Device Sequence Number: 21504932
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: 308142M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown