DISPOSABLE 23GA VITRECTOMY CUTTER NGP0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474534100), received between Jan 17, 2024 and Oct 31, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING PROCEDURE THE VITRECTOMY CUTTER DEVICE DIDN'T MOVE. PRIME AND TUNE HAD SUCCESSFULLY PASSED AND THE CUT RATE WAS CONFIRMED IN THREE STAGES 50, 500 AND 2500. THE ACCOUNT INDICATED THAT THE PATIENT'S VITREOUS BODY WAS REMOVED USING A DIFFERENT METHOD AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THROUGH FOLLOW-UP, WE LEARNED, THAT THE PATIENT'S CAPSULE WAS DAMAGED DURING PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE VITRECTOMY CUTTER. A SEPARATE REPORT WILL BE SUBMITTED AGAINST VERITAS CONSOLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23438272 ↗
• InjuryOct 8, 2024Device Difficult to Setup or Prepare; Dull, Blunt; Device Difficult to Setup or Prepare; Dull, Blunt

  CUSTOMER HAD AN ISSUE WITH THE VITRECTOR, IT DID NOT CUT OR WAS NOT WORKING PROPERLY. PHYSICIAN WAS TRYING TO REMOVE THE CORTEX FROM THE CAPSULE BAG BECAUSE THERE WAS A SLIGHT TEAR. THE VITRECTOR WOULD NOT ASPIRATE OR CUT. THEY DID NOT USE A NEW ONE. PHYSICIAN DECIDED TO JUST INSERT THE LENS AND MOVE ON WITH REMAINING CORTEX. CASE WAS COMPLETED WITH NO PATIENT ADVERSE EFFECTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20397940 ↗
• InjurySep 13, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DOCTOR HAD AN UNPLANNED ANTERIOR VITRECTOMY WHILE USING THE VERITAS SYSTEM. IT WAS ALSO REPORTED THAT THE 3G VITRECTOMY CUTTER WOULD NOT CUT. THEY HAD TO CONVERT TO ANOTHER COMPANY'S SYSTEM FOR THE VITRECTOMY TO COMPLETE THE CASE. THIS ADDED ABOUT 20 MINUTES TO THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS REPORT AGAINST THE VITRECTOMY CUTTER. A SEPARATE REPORT WILL BE FILED AGAINST THE VERITAS SYSTEM.

  Patient problems: Eye Injury

  MAUDE report 20218323 ↗
• MalfunctionJul 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT DURING PROCEDURE WHILE USING THE DEVICE, A FOREIGN MATERIAL LIKE A WHITE SOLID, FLOWED BACK FROM THE SUCTION OPENING AND ENTERED THE PATIENTS EYE. THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704176 ↗
• InjuryJan 17, 2024Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED THAT THEY HAD TO DO A VITRECTOMY ON A PATIENT AND WHEN THEY STARTED, THE VITRECTOR WAS NOT CUTTING OR ASPIRATING. THEY LOWERED THE CUTTING SETTINGS ON THE WHITESTAR SIGNATURE PRO AND IT SEEMED TO WORK A LITTLE. THROUGH FOLLOW UP IT WAS REPORTED BY THE ACCOUNT THAT THE VITRECTOMY WAS UNPLANNED. IT WAS NOT REPORTED WHAT CAUSED IT.

  Patient problems: Eye Injury

  MAUDE report 18531275 ↗