EVA Vitrectomy Pack VGPC Input 25G 8300.25G02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872019024), received between Oct 14, 2017 and Mar 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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

• MalfunctionMar 16, 2018Material Integrity Problem; Material Integrity Problem

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN FRANCE. DURING SURGERY, THE TIP DETACHED FROM THE HANDLE BEFORE THE END OF THE SURGERY. AND DURING THE SURGERY, THERE WAS A TIME WITH NO LIGHT AT ALL. THERE IS NO AVAILABLE INFORMATION ON THE STATUS OF THE PATIENT THEREFORE WE ASSUME NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345626 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS INCIDENT OCCURRED DURING SURGERY FROM A FACILITY IN (B)(6). THE FOLLOWING WAS REPORTED: FROM ASPIRATION PORT DURING VITRECTOMY, MOST OF THE TIME THE AIR BUBBLES WERE COMING AWAY. THE VITRECTOME WAS REPLACED, HOWEVER, SAME PROBLEM. THEN CHANGED INTO 23G FOR ANTERIOR CHAMBER. AGAIN, AIR BUBBLES COMING FROM ASPIRATION PORT. WHEN NURSE PUT THE VITRECTOME TO CUP WITH BSS, PRESSED THE FOOTSWITCH, I SAW AIR BUBBLES PASSING THROUGH THE ASPIRATION LINE TO THE CARTRIDGE, DESPITE THE ASPIRATION PORT WAS FULLY SINK IN THE BSS. THERE IS NO FURTHER INFORMATION. THERE IS NO REPORT OF PATIENT ILL EFFECT. NO SAMPLE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216946 ↗
• MalfunctionOct 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED THAT OCCURRED IN (B)(6). TODAY WE FACED A NEW AND VERY SERIOUS ISSUE AND WE ARE TRYING TO UNDERSTAND THE REASONS FOR IT. IT WAS REPORTED BUBBLES FROM THE ASPIRATION PORT OF THE CUTTER AT HIGH CUT RATE-SHAVING. THERE IS NO INFORMATION OF A PATIENT INJURY. ALL INFORMATION HAS BEEN PROVIDED. NO SAMPLE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950402 ↗

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.