FDA Adverse Event
Injury
Summary report: N
VIA360 SURGICAL SYSTEM
MDR report key: 23241300
·
Received October 7, 2025
Report
- Report Number
- 1000125279-2025-00032
- Event Type
- Injury
- Date Received
- October 7, 2025
- Date of Event
- September 5, 2025
- Report Date
- October 6, 2025
- Manufacturer
- NEW WORLD MEDICAL, INC.
- Product Code
- HMZ
- PMA / PMN Number
- K243503
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE IRIS INJURY, TEAR, OR IRIDODIALYSIS 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.
Description of Event or Problem · 0
SURGEON CREATED AN IRIS CLEFT WHILE USING A VIA360.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2508245 | VIA360 SURGICAL SYSTEM | INFUSION PUMP | HMZ | NEW WORLD MEDICAL, INC. | VIA360 | F0525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |