MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST; ARCDUO 9MM GUIDED CRI

Model Number	ARC-0002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedures and patients were scheduled with dr.(b)(6) and took place at specialty in (b)(6).During the second demo, suction was successful.Dr.(b)(6) placed the blades correctly and performed a first turn.Removed the blades and the device.Only one arc was successful, upon which dr.(b)(6) went back to perform a second procedure without removing the first blade on the side of the successful arc.After the second attempt the first arc appeared unchanged, and the second arc failed to materialize.Dr.(b)(6) resumed the case and went into phaco.As fluidics started leaking out of the arc dr.(b)(6) realized he had perforated the cornea.He finished his phaco case and sutured the arc with 4 stitches.

• Brand Name: MST
• Common Device Name: ARCDUO 9MM GUIDED CRI
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: yamini nidumolu ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 24879883
• Report Number: 3019924-2026-00088
• Device Sequence Number: 15911423
• Product Code: HNN
• UDI-Device Identifier: 00844685014316
• UDI-Public: 00844685014316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial

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: ARC-0002
• Device Catalogue Number: ARC-0002
• Device Lot Number: 213310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown