Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range 8268.VIT25Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717872020808), received between Nov 14, 2017 and Jul 11, 2018 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2018Contamination /Decontamination Problem

  WE LEARNED FROM A NURSE WHO CALLED IN LATER IN THE AFTERNOON THAT DURING A PHACO PROCEDURE METAL PARTICLES WERE FLUSHED INTO THE ANTERIOR CHAMBER FROM A PATIENT'S EYE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7677696 ↗
• MalfunctionJul 9, 2018Device Contamination with Chemical or Other Material

  THERE IS SOMETHING WHITE ON THE TIP.

  Patient problems: No Information

  MAUDE report 7670761 ↗
• MalfunctionJul 2, 2018Device Operational Issue; Device Operational Issue

  THERE WAS A LOT OF AIR BUBBLES COMING OUT FROM THE CUTTER. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655141 ↗
• MalfunctionJun 4, 2018Device Operational Issue; Device Operational Issue

  AIR CAME OUT FROM THE TIP. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566563 ↗
• MalfunctionJun 4, 2018Device Operational Issue; Device Contamination with Chemical or Other Material; Device Operational Issue; Device Contamination with Chemical or Other Material

  AIR BUBBLES CAME OUT FROM 25G TDC CUTTER TIP DURING PERIPHERAL SHAVING OF AN EYE WITH DETACHED RETINA. CUT RATE:8000CPM, VACUUM:650MMHG, FLOW:10CC/MIN, IV BOTTLE HEIGHT:50CM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565058 ↗
• MalfunctionMay 23, 2018Physical Property Issue; Physical Property Issue

  A DEMO WAS BEING PERFORMED. THE PROCEDURE WAS A RETINAL DETACHMENT. THE SURGEON PRACTICED A CORE VITRECTOMY AND WENT TO PERIPHERAL VITRECTOMY. SETTINGS 2500 TO 7000CPM , FLOW MODE 350MMHG 0->3.5 CC/MN WHEN SUDDENLY, BUBBLES CAME OUT OF THE VITRECTOMY NEEDLE. THE SURGEON WAS ASKED TO RETRIEVE AND CHECK THE VITRECTOMY IN A CUP AND WHEN SHE WAS ABOUT TO RE INSERT THE NEEDLE IN THE EYE, THE VITRECTOMY BURST OUT IN TWO PARTS, THE CAP IN ONE PART, AND THE VIT ON THE OTHER. WHEN YOU CAREFULLY LOOK AT THE VITRECTOMY IT SEEMS THERE NO GLUE OR SEAL SYSTEM ON IT. THE PATIENT HAS NOT BEEN WOUNDED BUT A LITTLE CONJUNCTIVA HEMORRHAGE, BUT WE WERE CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537770 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  DURING OPERATION, AIR BUBBLE HAPPENED. SITUATION IS AS FOLLOWS; EVA SHAVING MODE, 8000CPM, FLOW:SS, VACCUME 600. PLEASE INVESTIGATE IT CAREFULLY AND FIND ROOT CAUSE, AND IMPROVE. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518018 ↗
• MalfunctionApr 13, 2018Device Operational Issue; Device Operational Issue

  A REPORT FROM (B)(6) HAS BEEN RECEIVED. THE FOLLOWING HAS BEEN REPORTED: BUBBLES IN THE ABOVE MENTIONED CUTTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429036 ↗
• MalfunctionApr 6, 2018Material Separation; Material Separation

  A REPORT HAS BEEN RECEIVED FROM (B)(6) REPORTING SMALL PIECE OF METAL FROM VITRECTOR FELL DOWN ON THE RETINA DURING VITRECTOMY. IT LOOKED LIKE THE PART OF INTERNAL GUILLOTINE. THE SURGERY WAS COMPLETED WITH AN EQUIVALENT DEVICE/PACK. THERE IS NO INDICATION OF AN INJURY OR THAT ANY MEDICAL INTERVENTION HAD OCCURRED DUE TO THE EVENT. A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7403607 ↗
• MalfunctionNov 14, 2017Air Leak

  A REPORT HAS BEEN RECEIVED FROM (B)(6). THE FOLLOWING INCIDENT HAS BEEN REPORTED. MASSIVE AMOUNT OF AIR BUBBLES CAME OUT FROM 8268VIT25 DURING SURGERY. THE ACTUAL ITEM IS DISPOSED OF AND CANNOT BE RETURNED TO DORC. THERE IS NO INFORMATION OF AN INJURY THAT HAD OCCURRED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7031947 ↗

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.