MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC MST; MALYUGIN RING SYSTEM 7MM

Model Number	MAL-0002-1
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Yesterday dr.(b)(6) used the 7.00mm ring and she claimed one of the springs is defective.She stated that the defective spring torn the iris.Follow up info from the doctor: it was phaco surgery.The iris was incarcerated into the ringlet and required manipulation with a sinsky and kuglen to free it.On inspection after the case, the ringlet was found to have significant narrowing and an irregularity/burr within the ringlet.I tamponade the heme and pressurized the eye, which fortunately was enough to control the bleeding.It appeared to result in a small 1 clock hour iridodialysis, but he is not complaining of light sensitivity at this point, so i am observing him for now.

• Brand Name: MST
• Common Device Name: MALYUGIN RING SYSTEM 7MM
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond 98052
• Manufacturer Contact: yamini nidumolu ; 8415 154th ave ne; redmond 98052 ; 4255560544
• MDR Report Key: 23084970
• Report Number: 3019924-2025-00008
• Device Sequence Number: 10508788
• Product Code: HOC
• UDI-Device Identifier: 00844685000043
• UDI-Public: 00844685000043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Device Lot Number: 208191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown