VIA360 Surgical SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00892064002362), received between Jun 10, 2025 and Dec 11, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 23779959 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CATHETER TIP BROKE OFF IN THE CANAL DURING TRABECULOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475775 ↗
• InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ONE PATIENT EXPERIENCED IRIS PROLAPSE.

  Patient problems: Prolapse

  MAUDE report 22179296 ↗