Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max. 2267.NMD06Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717872008578), received between Feb 19, 2018 and Jul 2, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (6 reports).

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.

• MalfunctionJul 2, 2018Device Operational Issue; Device Operational Issue

  AIR BUBBLES ARE COMING OUT OF THE VITRECTOME (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655305 ↗
• MalfunctionMay 25, 2018Device Operational Issue; Device Operational Issue

  LASER PROBE DAMAGED ON THE MIDDLE OF THE CABLE/FIBER. LOOKED AT IT WITHOUT SAFETY GOGGLES. NORMALLY I LOOK THROUGH THE MICROSCOPE WITH FILTER, BUT AS IT DID NOT CAME/APPEARED ANY LASER EFFECTS I LOOKED TO THE SIDE. THE NEXT DAY I FELT BLINDED/DAZZLED. PRETTY SERIOUS I THINK. THERE IS NO FURTHER INFORMATION ON THE HEALTH STATUS. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544617 ↗
• MalfunctionMay 25, 2018Device Operational Issue; Device Operational Issue

  CUSTOMER IS USING A UST AND THE UNIT IS RUNNING IN THE 2X MODE WITH A STELLARIS PC ( 3500 CCP ). THEY USE TDC VITRECTOMES AND THE COMPLAINT IS THAT AIR BUBBLES COMES OUT THE CUTTER-HOLE IN TO THE EYE. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544465 ↗
• MalfunctionMay 24, 2018Device Operational Issue; Device Operational Issue

  CUSTOMER IS USING A UST. THE UNIT IS RUNNING IN THE 2X MODE WITH A STELLARIS PC ( 3500 CCP ). THEY USE TDC VITRECTOMES AND THE COMPLAINT IS THAT AIR BUBBLES COME OUT THE CUTTER HOLE IN TO THE EYE. THERE IS NO INFORMATION SUGGESTING PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542592 ↗
• MalfunctionMay 24, 2018Device Operational Issue; Device Operational Issue

  CUSTOMER IS USING A UST. THE UNIT IS RUNNING IN THE 2X MODE WITH A STELLARIS PC ( 3500 CCP ). THEY USE TDC VITRECTOMIES AND THE COMPLAINT IS THAT AIR BUBBLES COME OUT THE CUTTER HOLE IN TO THE EYE. THERE IS NO INFORMATION SUGGESTING PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542582 ↗
• MalfunctionFeb 19, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF ANY INCIDENT THAT OCCURRED IN (B)(6). THE FOLLOWING WAS REPORTED: AS DISCUSSED, DURING THE VITRECTOMY DEMO DURING SURGERY, THE CUTTER HAD BUBBLES POPPING OUT FROM THE CUTTER PORT. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281243 ↗