2.2 mm Triple step flared phaco needle. (disposable) 8400.22F01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717872018751), received between Feb 13, 2018 and Feb 16, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2018Physical Property Issue; Physical Property Issue

  A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6). "WE RECEIVED A COMPLAINT CONCERNING PHACO TIPS " TWO SMALL METALLIC ""PAILLETTE"" FELL FROM THE TIP IN TO THE EYE. NO CONSEQUENCE FOR THE PATIENT, THE SURGEON ASPIRATED IT. THERE IS NO FURTHER INFORMATION. NO SAMPLE WAS RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7278529 ↗
• InjuryFeb 13, 2018Material Separation; Material Separation

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURED IN (B)(6). THE FOLLOWING WAS REPORTED :A METAL PART WAS FLUSHED INTO THE EYE DURING THE SURGERY. THE CASE HAS BEEN FINISHED WITH A SHORT DELAY FOR REMOVING THE PART FROM THE EYE. NO HARM OR ILL EFFECT HAS BEEN REPORTED. THE HAND PIECE CANNOT BE RETURNED BY THE HOSPITAL AND THE METAL PIECE CONCERNED WAS DISCARDED. THE PHACO NEEDLE HAS BEEN RETURNED IS CURRENTLY UNDERGOING INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7266597 ↗

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.