EVA Vitrectomy Pack Gravity Input 23G 8300.23G01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717872018997), received between Mar 21, 2018 and Jun 13, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2018Material Separation; Material Separation

  THE PROBE WAS SEPARATED AT THE BACK AFTER 5 SECONDS OF OPERATION. ALSO AIR COMING FROM THE PROBE TIP. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596791 ↗
• MalfunctionJun 13, 2018Material Separation; Material Separation

  THE PROBE WAS SEPARATED AT THE BACK AFTER 5 SECONDS OF OPERATION. ALSO AIR COMING FROM THE PROBE TIP. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596785 ↗
• MalfunctionJun 13, 2018Material Separation; Material Separation

  THE PROBE WAS SEPARATED AT THE BACK AFTER 5 SECONDS OF OPERATION. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596732 ↗
• InjuryMar 21, 2018Partial Blockage; Partial Blockage

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN (B)(6) THE FOLLOWING WAS REPORTED: "WE RECEIVED AN OFFICIAL COMPLAINT CONCERNING A PROBLEM WITH THE INFUSION LINE. AT THE BEGINNING OF THE 23G VITRECTOMY, EYE WITHOUT TONE. BAD IRRIGATION. THE INFUSION LINE SHOW A DEFECT AT THE OUTPUT. EYE WITHOUT TONE - (SERIOUS RISK TO THE PATIENT).

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 7359528 ↗

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.