EVA Custom TDC Vitrectomy Pack VGPC Input 25G 8525.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717872021294), received between Jun 4, 2018 and Jun 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operational Issue” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2019Class IIOpen, Classified

   Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

   Z-2252-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2018Device Operational Issue; Device Operational Issue

  THE COMPLAINANT INFORMED THAT THE INFUSION OF THE SYSTEM WAS INSUFFICIENT TO MAINTAIN ADEQUATE PRESSURE IN THE EYE, UNDER BOTH FLUID AND AIR. INFUSION WAS RAISED FROM 40 MMHG TO 150 MMHG, AND STILL PRODUCED INSUFFICIENT GLOBE PRESSURE. THE INFUSION LINE WAS REPLACED AND THE CASE WAS COMPLETED AT 150 MMHG (WHICH IS HIGH). THE SURGEON INSISTED THE PRESSURE WAS INSUFFICIENT THROUGHOUT THE CASE. THE COMPLAINT ITEM WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565341 ↗