EVA Custom TDC Vitrectomy Pack VGPC Input 23G 8523.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872021287), received between Apr 13, 2018 and Jul 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 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.

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

  WE RECEIVED A COMPLAINT THAT REPORTED OUT OF THIS PACK: CUTTER DID NOT CUT, HIGH INFUSION LINE DROPPED OFF TROCAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656459 ↗
• MalfunctionApr 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A REPORT FROM (B)(6) HAS BEEN RECEIVED. THE FOLLOWING HAS BEEN REPORTED: LINT AT THE HIGH INFUSION LINE - SEE FILM USB STICK. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431563 ↗
• MalfunctionApr 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A REPORT FROM (B)(6) HAS BEEN RECEIVED. THE FOLLOWING HAS BEEN REPORTED: DISCOVERED WHITE STAINS ON THE TROCARS (THE KNIFE AS WELL AND THE SHAFT). ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431170 ↗

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.