Disposable High Speed Cutter 23G/8000CPM 8267.VIT23Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717872019093), received between Oct 12, 2017 and Jul 5, 2018 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue

  STARTING WITH CORE VITRECTOMY NO COMPLAINT BUT WHEN SWITCHING OVER TO PERIPHERAL VITRECTOMY CUTTER PRODUCED A LOT OF AIR BUBBLES INTO THE EYE. FLUID LINES FROM BOTTLE WERE CHECKED. CUTTER ALSO CHECKED AND TRIED INTO SEPARATE GALLIPOT WITH BSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665321 ↗
• MalfunctionJul 2, 2018Device Operational Issue; Device Operational Issue

  BUBBLE, WEAK ASPIRATION. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655078 ↗
• MalfunctionJun 22, 2018Device Operational Issue; Device Operational Issue

  FIRST TIME IT WAS OK, BUT BUBBLES CAME OUT WHEN SECOND TIME, AND AFTER A WHILE, IT GOT BETTER AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631161 ↗
• MalfunctionMay 11, 2018Device Operational Issue; Device Operational Issue

  AIR BUBBLE. SAMPLE IS AVAILABLE. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508516 ↗
• MalfunctionMay 10, 2018Device Operational Issue; Device Operational Issue

  DURING USE WITH EVA, AIR BUBBLE CAME OUT FROM THE CUTTER EDGE PART. PLEASE INVESTIGATE IT URGENTLY AND LET US KNOW THE CAUSE AND COUNTERMEASURE. SAMPLE AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503019 ↗
• MalfunctionMay 9, 2018Device Operational Issue; Device Operational Issue

  IN (B)(6), ONE VITRECTOME CAUSED BUBBLES DURING THE SURGERY. NO REPORT OF AN INJURY. ALL INFORMATION HAS BEEN DISCLOSED. A SAMPLE IS AVAILABLE FOR AN EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500469 ↗
• MalfunctionMay 7, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE (B)(6). THE VITRECTOMY DOES NOT SUCK WELL AND SPITS AIR. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492567 ↗
• MalfunctionMay 7, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE NETHERLANDS. THE VITRECTOMY DOES NOT SUCK HARDLY AND CALLS. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492297 ↗
• MalfunctionMay 7, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE NETHERLANDS. THE VITRECTOMY HAS AIR BUBBLES IN THE SYSTEM. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490755 ↗
• MalfunctionMay 7, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE NETHERLANDS. THE VITRECTOMY HAS SPIT BUBBLES. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490732 ↗
• MalfunctionMay 7, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE NETHERLANDS. THE VITRECTOMY SPITS AIR. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490528 ↗
• MalfunctionMay 4, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT AN EVENT THAT OCCURRED IN THE (B)(6). THE VICTRECTOOM SPITS ON THE OCCURRENCE AND DOES NOT SUCK WELL. VITRECTOOM SPIT BUBBLES. VITRECTOOM ALWAYS GIVES AIR TO THE SYSTEM. THERE IS NO FURTHER INFORMATION AND ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488475 ↗
• MalfunctionApr 15, 2018Device Operational Issue; Device Operational Issue

  A HOSPITAL IN (B)(6) HAS REPORTED THE FOLLOWING INCIDENT TO THE DISTRIBUTOR: DURING OPERATION WITH (B)(6), LOTS OF AIR BUBBLE CAME OUT FROM THE CUTTER. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431856 ↗
• MalfunctionApr 15, 2018Device Operational Issue; Device Operational Issue

  A REPORT FROM IRAN HAS BEEN RECEIVED REPORTING THE FOLLOWING: THESE PROBES WERE FROM THE SAME LOT NUMBER THAT WE HAD BUBBLING PROBLEM WITH THEM. SAMPLES ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431849 ↗
• MalfunctionFeb 8, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT OCCURRING IN (B)(6). PREVIOUSLY,WE NOTICED THE BUBBLES POPPING OUT FROM CUTTER. SO, WE SIMPLY CHANGE THE CUTTER DURING THE SURGERY. THERE IS NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7252736 ↗
• MalfunctionFeb 7, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN (B)(6). PREVIOUSLY,WE NOTICED THE BUBBLES POPPING OUT FROM CUTTER. SO,WE SIMPLY USE TO CHANGE THE CUTTER DURING THE SURGERY OF THE DEFECTIVE CUTTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249029 ↗
• MalfunctionFeb 7, 2018Device Operational Issue; Device Operational Issue

  A REPORT WAS RECEIVED OF AN INCIDENT OCCURRING IN (B)(6). PREVIOUSLY,WE ALSO NOTICED THE BUBBLES POPPING OUT FROM CUTTER. WE SIMPLY CHANGE THE CUTTER DURING THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248907 ↗
• MalfunctionFeb 6, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6). THE REPORT INCLUDED: I SHOULD INFORM YOU THAT WE`VE RECEIVED A COMPLAINT ABOUT THE 8267. VIT23 PROBE FROM THE HOSPITAL. THE SURGEON CLAIMED A LOT OF AIR BUBBLES FROM THE TIP OF THE PROBE DURING THE SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245000 ↗
• MalfunctionFeb 6, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED IN (B)(6). THE REPORT INCLUDED: I SHOULD INFORM YOU THAT WE`VE RECEIVED A COMPLAINT ABOUT THE 8267.VIT23 PROBE FROM THE HOSPITAL. THE SURGEON CLAIMED A LOT OF AIR BUBBLES FROM THE TIP OF THE PROBE DURING THE SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244922 ↗
• MalfunctionJan 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED REPORTING AIR BUBBLES. THERE IS NO FURTHER INFORMATION. NO SAMPLE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222027 ↗
• MalfunctionJan 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED WHERE BUBBLES CAME OUT OF THE CUTTER. IT WAS REPORTED THAT THEY THINK THAT THE MEMBRANE IS LEAKING. THERE IS NO REPORT OF PATIENT INJURY OR HARM AND IT IS UNKNOWN WHEN THIS EVENT OCCURRED. NO SAMPLE WAS RETURNED FOR AN EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222024 ↗
• MalfunctionOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AMERICAN HOSPITAL HAD PROBLEM WITH THE VITRECTOME DUE TO AIR BUBBLES. THERE IS NO INFORMATION OF PATIENT INJURY. THERE IS NO FURTHER INFORMATION. LIKELY OCCURRED DURING A SURGERY BUT WE HAVE NO FURTHER INFORMATION ON THE OUTCOME OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945668 ↗

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.