Disposable High Speed Cutter 20G/8000CPM 8267.VIT20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717872019109), received between Oct 12, 2017 and Jun 26, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue

  THE VITRECTOOM GAVE AIR BUBBLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638191 ↗
• MalfunctionMay 16, 2018Physical Property Issue; Physical Property Issue

  THE VITRECTOOM SPITS AIR ACCORDING TO THE CUSTOMER. SAMPLE AVAILABLE. NO ILL EFFECT TO PATIENT REPORTED. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520691 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  BUBBLES ON THE TIP DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7514034 ↗
• MalfunctionMay 9, 2018Device Operational Issue; Device Operational Issue

  THERE WAS A BUBBLE (SILICONE) ON THE VITRETOME WHILE THE PATIENT`S EYE HAD NEVER HAD SURGERY BEFORE. THE BUBBLE DID NOT COME OUT OF ANYTHING BUT WAS ON THE SILICONE FROM THE START OF VITRECTOMY. THE BUBBLE REMAINED GLUED TO VITRECTOMY THROUGHOUT THE PROCEDURE. ALL INFORMATION HAS BEEN DISCLOSED. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7498174 ↗
• MalfunctionOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED FROM (B)(6) REPORTING THE FOLLOWING EVENT THAT THE DEVICE HAS A LOOSE HANDLE AND GIVES BUBBLES. LIKELY OCCURRED DURING SURGERY. THERE IS NO INFORMATION OF ANY INJURY OR OUTCOME OF THE PATIENT. THE SAMPLE IS AVAILABLE FOR AN EVALUATION.

  Patient problems: No Information

  MAUDE report 6945763 ↗
• 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. NO FURTHER INFORMATION IS AVAILABLE AS TO THE DETAIL REGARDING WHAT INJURY HAD OCCURRED OR THE OUTCOME.

  Patient problems: Eye Injury

  MAUDE report 6944327 ↗

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.