EVA TDC Vitrectomy Pack VGPC Input 23G 8310.23G02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717872021010), received between Feb 6, 2018 and Jun 29, 2018 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2018Material Separation; Material Separation

  DURING A SURGERY THE SURGEON FOUND A METAL PIECE IN THE EYE. THE METAL CAN ONLY BE OF THE TROCAR, CUTTER OR LIGHT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7652808 ↗
• MalfunctionJun 20, 2018Device Operational Issue; Device Operational Issue

  WHILE I WAS DOING CENTRAL VITRECTOMY BIG BUBBLES CAME OUT OF THE VITRECTOME PORT, THIS WAS NOT THE VERY SMALL BUBBLES I USED TO SEE IN THE FIRST SURGERIES WITH THE SYSTEM, THESE ARE REALLY BIG BUBBLES WHICH EVEN MAY CAUSE DAMAGE TO THE CRYSTALLINE LENS AND THEY DON'T LET YOU WORK PROPERLY, THE VITRECTOME IS A BUBBLE MAKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7621683 ↗
• MalfunctionApr 16, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT OCCURRING IN (B)(6). THE FOLLOWING WAS REPORTED: THE VITRECTOME WAS GIVING OFF BUBBLES DURING USE AND HAD TO BE REPLACED IN ORDER TO CONTINUE THE SURGERY. NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432653 ↗
• InjuryMar 23, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THIS EVENT OCCURRED DURING SURGERY FOR A RETINAL DETACHMENT. PRESSURE WITHIN THE EYE COULD NOT BE MAINTAINED. CHOROIDALS OCCURRED CONTINUALLY WITH ANY TYPE OF ASPIRATION. STAFF CHECKED THE STOP COCK FOR AN AIR LOCK. THE PRESSURE WAS ADJUSTED AND AIC TO ABOVE NORMAL RANGES IN AN ATTEMPT TO MAINTAIN PRESSURE. THE BOTTLE OF BSS WAS "SHOOK." IT WAS THEN IDENTIFIED THAT THE METAL SNORKET/BSS PORTION OF THE TUBING MAY HAVE BEEN BLOCKED BY GLUE OR POSSIBLY BENT. THIS CASE WAS COMPLETED WITH USE OF THIS PACK AND AFTER THE BOTTLE WAS "SHOOK" PRESSURE WAS MAINTAINED DURING ASPIRATION. IT WAS LEARNED THAT POST OP ON THE FOLLOWING DAY, THE RETINA DETACHED AND FOLDED. IT WAS REPORTED THAT THE SURGEON DID NOT ATTRIBUTE THIS TO THE PACK/INFUSION ISSUE. A SAMPLE IS AVAILABLE FOR EVALUATION. WE HAVE REACHED OUT TO THE SURGEON. THE FOLLOWING HAS BEEN REPORTED. WERE THE CHOROIDALS PRESENT PRIOR TO SURGERY? NO; WE HAVE DOCUMENTED EXAM AND ULTRASOUND THAT THERE WERE NO CHOROIDALS PRESENT. WERE THE CHOROIDALS PRESENT AND THEN AGGRAVATED BY SURGERY? NO; AS ABOVE; THEY HAPPENED DURING SURGERY; COULD THE CHOROIDALS BE DUE TO AN UNDERLYING MEDICAL CONDITION? NO; SHE HAD A GIANT RETINAL TEAR BUT TO MY KNOWLE

  Patient problems: Eye Injury; Intraocular Pressure, Delayed, Uncontrolled; Retinal Injury; Vitritis

  MAUDE report 7365334 ↗
• MalfunctionMar 21, 2018Device Operational Issue; Device Operational Issue

  "THIS PACK HAD A VITRECTOME THAT IS INTRODUCING LARGE AMOUNT OF BUBBLES INTO THE EYE DURING VITRECTOMY. CUTTER HAD TO BE DISCARDED DUE TO CONTAMINATION BY PATIENT USE. PLEASE INVESTIGATE THE LOT NUMBER TO SEE IF IT IS BATCH ERROR WITH THE CUTTERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359708 ↗
• MalfunctionMar 7, 2018Device Operational Issue; Device Operational Issue

  A REPORT FROM A HOSPITAL HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN (B)(6): "WHEN OUR TEAM USED THIS PROBE, AIR BUBBLES ARE COMING OUT OF THE PROBE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321719 ↗
• MalfunctionFeb 6, 2018Physical Property Issue; Physical Property Issue

  SMALL PLASTIC PARTS CAME TROUGH THE INFUSION LINE. NO FURTHER INFORMATION IS AVAILABLE. NO SAMPLE IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7245855 ↗

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.