MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. VIA360 SURGICAL SYSTEM; INFUSION PUMP

Model Number	VIA360
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Prolapse (2475)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include iris injury as a known complication.The device history record for the reported lot was reviewed, and no issues were identified.The product was manufactured, tested, and released in accordance with validated procedures.As the device is not available for return, no device malfunction could be confirmed.
Event or Problem Description
One patient experienced iris prolapse.

• Brand Name: VIA360 SURGICAL SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 22179296
• Report Number: 1000125279-2025-00020
• Device Sequence Number: 15887617
• Product Code: HMZ
• UDI-Device Identifier: 00892064002362
• UDI-Public: (01)00892064002362(11)250318(17)260318(10)B0525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243503
• 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
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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 Expiration Date: 03/18/2026
• Device Model Number: VIA360
• Device Catalogue Number: VIA360
• Device Lot Number: B0525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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: Required Intervention
• Patient Sex: Unknown