MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. ALLEGRO SP; OPHTHALMIC CANNULA

Model Number	ASP-0001
Medical Device Problem Codes	Material Frayed (1262); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is 1 of 4.The dfu for the device instructs the user to inspect the device before use and if damage is present not to use the device and contact the manufacturer.The doctor chose to use the device even though it appeared to be out of specification.
Event or Problem Description
The doctor experienced capsule tears using allegro sp ia handpieces.Four separate patients were impacted by 4 different devices.All patients recovered with no intervention required.The procedure was completed as planned.

• Brand Name: ALLEGRO SP
• Common Device Name: OPHTHALMIC CANNULA
• 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: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 19283295
• Report Number: 3019924-2024-00003
• Device Sequence Number: 15306571
• Product Code: HMX
• UDI-Device Identifier: 00844685006809
• UDI-Public: 00844685006809
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: ASP-0001
• Device Catalogue Number: ASP-0001
• Device Lot Number: 187726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown