MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC ALLEGRO SINGLE USE SILICONE I/A TIPS; DEVICE, IRRIGATION, OCULAR SURGERY, PRODUCT CODE KYG

Model Number	AT-0001-R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A capsule breakage was noted with the mst tip on polishing.The patient has not experienced any permanent or temporary disorders and their daily activities were not significantly affected.A vitrectomy was required.A delay of five minutes occurred during the procedure and the end-user consulted a doctor but has not been prescribed any medications.Further details regarding the complaint are expected to be provided.

• Brand Name: ALLEGRO SINGLE USE SILICONE I/A TIPS
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY, PRODUCT CODE KYG
• 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: 22092434
• Report Number: 3019924-2025-00004
• Device Sequence Number: 7885788
• Product Code: KYG
• UDI-Device Identifier: 00844685005581
• UDI-Public: 00844685005581
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: AT-0001-R
• Device Catalogue Number: AT-0001-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/27/2025
• 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: Required Intervention
• Patient Sex: Unknown