EVA Vitrectomy Pack Gravity Input 25G 8300.25G01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717872019017), received between Jan 24, 2018 and Jun 27, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 other recall cover devices cleared under the same FDA submission (K190875); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2018Material Separation; Material Separation

  WE ARE GOING TO RECEIVE AN OFFICIAL MATERIOVIGILANCE CONCERNING VITRECTOME. THE TIP WAS EJECTED WHILE IT WAS INSERTED INTO THE EYE, FORTUNATELY THERE WERE NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642826 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS INCIDENT OCCURRED IN (B)(6). WE RECEIVED A COMPLAINT FROM A CLINIC CONCERNING THE VITRECTOME INCLUDED IN PACK WITH " BUBBLES " PROBLEMS. NO PATIENT INJURY WAS REPORTED. INFORMATION SUGGESTS THIS WAS DETECTED DURING A SURGICAL PROCEDURE, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. NO SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190875. One submission often covers many models, so check the product and lot details in each record.

• Z-2252-2021 · May 21, 2019 · Open, Classified
  The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.