DISPOSABLE 25GA VITRECTOMY CUTTER NGP0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474534117), received between Mar 24, 2017 and Aug 9, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 24, 2018Class IITerminated

   Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.

   Z-1893-2019 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25-GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20-GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 2 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 7767518 ↗
• MalfunctionAug 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25-GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20-GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 1 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 7767478 ↗
• MalfunctionAug 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25-GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20-GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 2 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 7767455 ↗
• MalfunctionAug 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25-GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20-GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 1 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 7767390 ↗
• MalfunctionJun 14, 2017Device Markings/Labelling Problem; Incorrect Device Or Component Shipped; Device Markings/Labelling Problem; Incorrect Device Or Component Shipped

  A SURGERY CENTER REPORTED MISLABELING OF A DISPOSABLE VITRECTOMY CUTTER. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25 GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20 GAUGE ENGRAVED ON THE DEVICE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6641789 ↗
• MalfunctionMar 24, 2017Device Markings/Labelling Problem; Incorrect Device Or Component Shipped; Device Markings/Labelling Problem; Incorrect Device Or Component Shipped

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25 GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20 GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 2 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 6430698 ↗
• MalfunctionMar 24, 2017Device Markings/Labelling Problem; Incorrect Device Or Component Shipped; Device Markings/Labelling Problem; Incorrect Device Or Component Shipped

  A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25 GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20 GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 1 OF 2 REPORTS.

  Patient problems: No Patient Involvement

  MAUDE report 6430697 ↗