EVA Vitrectomy Pack VGPC Input 23G 8300.23G02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717872019000), received between Oct 12, 2017 and Jul 9, 2018 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2018Defective Component; No Flow

  AN EMAIL WAS RECEIVED FROM THE SALES REP WHO SENT US A DEFECTIVE VGPC TUBING SET. ON 27MAR2017 FURTHER INFORMATION HAS BEEN RECEIVED. THE PRODUCT IDENTIFIED IN THIS INCIDENT IS ARTICLE #8300.23G02, LOT 2000381723 AND HAD BEEN PRIMED AND SURGERY WAS READY TO START. THERE WAS NO ERROR CODE OR ALERT; HOWEVER IT WAS NOTICED INSUFFICIENT INFUSION FLOW POST PRIME. THIS SET WAS TAKEN DOWN AND WAS SET UP AGAIN ON A DIFFERENT MACHINE WITH SAME ISSUE NOTED. THEREFORE IT IS LIKELY THE INCIDENT WAS CAUSED BY THIS SET. NO PATIENT INJURY AND SAMPLE WAS SAVED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669950 ↗
• MalfunctionMay 2, 2018Device Operational Issue; Device Operational Issue

  WE HAD PROBLEM WITH 1 VITRECTOOM. LITTLE AIR BUBBLES CAME FROM THIS VITRECTOOM. THIS VITRECTOOM IS AN ORDINARY 8000 CPM THAT COMES FROM THE PACK. A TDC VITREOUS WAS HANDED TO THE SURGEON SO THAT HE COULD DO THE SURGERY AND DID NOT HAVE TO OPEN A NEW PACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481003 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  (B)(6) HAS REPORTED THE FOLLOWING: THE MEMBRANE OF THE CUTTER OF THE KIT ARE DEFECT SO THAT AIR IS ENTERING THE EYE AND BUBBLES ARE CAUSED. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447317 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  (B)(6) HAS REPORTED THE FOLLOWING: THE MEMBRANE OF THE CUTTER OF THE KIT ARE DEFECT SO THAT AIR IS ENTERING THE EYE AND BUBBLES ARE CAUSED. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447285 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  (B)(6) HAS REPORTED THE FOLLOWING: THE MEMBRANE OF THE CUTTER OF THE KIT ARE DEFECT SO THAT AIR IS ENTERING THE EYE AND BUBBLES ARE CAUSED. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447254 ↗
• InjuryApr 15, 2018Air Leak

  A FACILITY FROM FRANCE HAS REPORTED THE FOLLOWING: THEY GOT A PROBLEM WITH THE PACK. VITRECTOM THROW AIR IN THE EYE DURING SURGERY IT IS A SERIOUS INCIDENT. NO FURTHER INFORMATION HAS BEEN RECEIVED. ALL INFORMATION HAS BEEN DISCLOSED. NO SAMPLE.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 7431859 ↗
• MalfunctionFeb 7, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN EVENT OCCURRING IN (B)(6). IT WAS LEARNED THE VITRECTOME WAS DEFECTIVE AS IT CONTAINED AIR BUBBLES. THERE IS NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248820 ↗
• MalfunctionJan 25, 2018Device Operational Issue; Device Operational Issue

  THE FOLLOWING INCIDENT HAS BEEN REPORTED BY A CLINIC FROM (B)(6). THE INCIDENT REPORTEDLY OCCURRED DURING SURGERY. DUE TO A LACK OF IRRIGATION THERE HAS BEEN SUDDEN DEPRESSION OF THE ANTERIOR CHAMBER. THE TUBING WAS BLOCKED. NO SAMPLE HAS BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7218220 ↗
• MalfunctionOct 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HOSPITAL FROM (B)(6) HAS REPORTED THE FOLLOWING PROBLEM THAT OCCURRED THE UNIT DIDN`T KEEP THE CARTRIDGE. IT THROWS OUT BUBBLES WITH THE VITRECTOME AND INFUSION LINE. NO SAMPLE IS AVAILABLE FOR AN EVALUATION. THERE IS NO INFORMATION OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950566 ↗
• MalfunctionOct 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED FROM (B)(6) REPORTING SEVERAL PROBLEMS. THE IRRIGATION TUBING WAS COMPLETELY CLAMPED. THEY REPLACE THE PACK. THE FOLLOWING PROBLEM OCCURRED SEVERAL TIMES WITH THE SAME PACK. BUBBLES WITH THE VITRECTOME AND INFUSION LINE. THERE IS NO SAMPLE AS IT WAS DISCARDED. INFORMATION SUGGESTS THAT THE EVENT OCCURRED DURING SURGERY AND THERE IS NO INFORMATION THAT THE PATIENT WAS HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950379 ↗
• InjuryOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS INCIDENT OCCURRED DURING SURGERY. AIR BUBBLES WERE OBSERVED AND CAUSED INJURY TO PATIENTS EYE, HENCE THIS COMPLAINT IS CONCLUDED AS REPORTABLE. THERE IS NO FURTHER INFORMATION ON THE INJURY OR THE OUTCOME. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: Eye Injury

  MAUDE report 6945519 ↗

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.