Disposable High Speed TDC Cutter 23 G / 8000 CPM DORC Continuum range 8268.VIT23Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717872020792), received between Jan 11, 2018 and Jul 9, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (5 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.

• MalfunctionJul 9, 2018Insufficient Device Problem Information

  OUR CUSTOMER COMPLAINED ABOUT THE INFUSION LINE,WHICH IS ONLY PARTIAL, THROUGH THAT THE EYE COLLAPSED DURING VITRECTOMY.

  Patient problems: Eye Injury

  MAUDE report 7670033 ↗
• MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue

  AIR BUBBLES COMING OUT OF THE CUTTER, WHEN ACTIVATED. THE LOT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665460 ↗
• MalfunctionJun 14, 2018Device Operational Issue; Device Operational Issue

  BUBBLE HAPPENS. SAMPLE WAS SAVED AND SENT FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600729 ↗
• MalfunctionMay 24, 2018Device Operational Issue; Device Operational Issue

  CUSTOMER CLAIMED OUR CUTTER MAKES BUBBLES, PLEASE FIND ATTACHED THE CLAIM. PLEASE CHECK AND LET US HAVE YOUR REPLY. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7541053 ↗
• MalfunctionMay 11, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT YOU THAT WE HAVE A BUBBLING ISSUE WITH 8268.VIT. OCCURED AT THE BEGINNING OF THE SURGERY WITH HIGHER CUT RATE. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507270 ↗
• MalfunctionApr 16, 2018Device Operational Issue; Device Operational Issue

  OUR CUSTOMER DISCOVERED BUBBLES WHEN USING 8268.VIT23. INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434944 ↗
• InjuryJan 11, 2018Air Leak; Device Misassembled During Manufacturing /Shipping; Device Operates Differently Than Expected; Noise, Audible; Device Misassembled During Manufacturing /Shipping

  DURING THE VITRECTOMY SURGERY, THE SURGEON HEARD A SUDDEN BLASTING SOUND IN THE VITRECTOME CUTTER. AFTERWARDS THE CUTTING DID NOT WORK, WITH STRONG AIR BUBBLES CAME OUT FROM THE TIP OF THE VITRECTOME INSTEAD. THIS CAUSED DAMAGE TO THE PATIENT'S RETINA. INJECTED GAS INSTANTLY DAMAGED THE PERIPHERAL RETINA. FORTUNATELY, THE TEAR WAS FAR FROM MACULA; IN THE END, THE PATIENT'S VISION WAS NOT OBVIOUSLY IMPACTED. THE INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL WILL BE FILED ONCE COMPLETE.

  Patient problems: Eye Injury

  MAUDE report 7184676 ↗

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.