MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC 22G CURVED ASPIRATOR, .3 MM PORT; DEVICE IRRIGATION, OCULAR SURGERY

Model Number	DU-02355
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the use of a signature pro phacoemulsifier the surgeon observed a suspicious deposit in the patient's eye that may have originated from the disposable in question.Follow up: there was no patient's injury but a small piece of metal remains in the patient's eye.

• Brand Name: 22G CURVED ASPIRATOR, .3 MM PORT
• Common Device Name: DEVICE IRRIGATION, OCULAR SURGERY
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: yamini nidumolu ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 22301281
• Report Number: 3019924-2025-00006
• Device Sequence Number: 15601897
• Product Code: KYG
• UDI-Device Identifier: 00844685002061
• UDI-Public: 00844685002061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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
• Device Model Number: DU-02355
• Device Catalogue Number: DU-02355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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