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

Model Number	VIA 360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include hyphema as a known complication.Additionally, the ifu states that the surgeon should monitor and manage intraocular pressure postoperatively if it is not adequately maintained.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
A surgeon used a via360 from my trunk stock for evaluation.The device was used without incident or complication.I posted in salesforce that when i checked in to follow up with the surgeon post op day 1, the surgeon informed me that the patients iop was elevated off glaucoma meds, and that a microhyphema was visible.

• 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: 23779959
• Report Number: 1000125279-2025-00047
• Device Sequence Number: 18663020
• Product Code: HMZ
• UDI-Device Identifier: 00892064002362
• UDI-Public: (01)00892064002362(11)250816(17)260816(10)H2125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2026
• Device Model Number: VIA 360
• Device Catalogue Number: VIA 360
• Device Lot Number: H2125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2025
• 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