DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI NGP0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474534094), received between Jun 23, 2022 and Feb 7, 2025 — classified as 3 injuries.

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

• InjuryFeb 7, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED THAT THEIR SURGICAL ADJUNCT DEVICE MALFUNCTIONED DURING A CATARACT SURGERY, RESULTING IN A POSTERIOR CAPSULE TEAR IN PATIENT'S OCULUS DEXTER (OD) RIGHT EYE. THE DEVICE'S TIP WAS FOUND TO BE NON-FUNCTIONAL UPON TESTING, NECESSITATING THE USE OF A NEW DEVICE TO COMPLETE THE PROCEDURE. A VITRECTOMY WAS PERFORMED. THE INTRAOCULAR AR40E LENS WITH SERIAL NUMBER (B)(6) WAS IMPLANTED. THE PATIENT IS REPORTED TO BE FINE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21339489 ↗
• InjuryJun 23, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT AN ANTERIOR VITRECTOMY WAS NECESSARY DUE TO RUPTURE OF THE POSTERIOR LENS CAPSULE DURING CATARACT SURGERY USING THE PHACOEMULSIFICATION TECHNIQUE. THIS WAS USING THE COMPACT INTUITIVE SYSTEM AND A VITRECTOMY PROBE WHICH DIDN'T WORK THEREFORE, PATIENT WAS TRANSFERRED TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE VITRECTOMY CUTTER. REFER TO 3012236936-2022-01677 FOR THE REPORT OF THE COMPACT INTUITIVE SYSTEM.

  Patient problems: Capsular Bag Tear

  MAUDE report 14795320 ↗
• InjuryJun 23, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT AN ANTERIOR VITRECTOMY WAS NECESSARY DUE TO RUPTURE OF THE POSTERIOR LENS CAPSULE DURING CATARACT SURGERY USING THE PHACOEMULSIFICATION TECHNIQUE. THIS WAS USING THE COMPACT INTUITIVE SYSTEM AND A VITRECTOMY PROBE WHICH DIDN'T WORK THEREFORE, PATIENT WAS TRANSFERRED TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE VITRECTOMY CUTTER. REFER TO 3012236936-2022-01675 FOR THE REPORT OF THE COMPACT INTUITIVE SYSTEM.

  Patient problems: Capsular Bag Tear

  MAUDE report 14794771 ↗