MAUDE Adverse Event Report: MILLENNIUM SURGICAL; REV DESCRIPTIONKOCH SPATULA AND NAGAHARA CHOPPER DE

Model Number	92-H0499
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device lot number was not provided, ship date or contact for incident.
Event or Problem Description
On 02 jan 2026 a notification from the fda indicating that a medwatch report was issued on (b)(6) 2025 for millennium surgical item # 92-h0499 below is the information provided via the medwatch report (mw5180236).Patient was scheduled for cataract extraction with intraocular lens implantation of the left eye.During the phacoemulsification portion after inserting the chopper side and initiating cataract fragmentation, doctor noticed that the tip of the chopper broke off and remained inside the patient's eye.Upon confirming visualization of the broken tip, doctor successfully retrieved it from the eye.The procedure continued and was completed without any further complications.

• Brand Name: MILLENNIUM SURGICAL
• Common Device Name: REV DESCRIPTIONKOCH SPATULA AND NAGAHARA CHOPPER DE
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumberg, IL 60173 ; 8479080292
• MDR Report Key: 24227867
• Report Number: 1421101-2026-00001
• Device Sequence Number: 18437602
• Product Code: HNQ
• UDI-Device Identifier: 00190776202965
• UDI-Public: 00190776202965
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 92-H0499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• 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