2.5 mm Triple step angled flared phaco needle. (disposable) 8400.25A01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717872018775), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2018Material Separation; Material Separation

  DURING SURGERY, THE SURGEON REALIZED THAT THERE WAS A LOOSE TIP OF METAL ON THE TIP OF A PHACO WHICH HAD NOT BROKEN YET. THIS WAS WHILE THE PHACO WAS INSIDE THE PATIENT`S EYE AND DOCTOR HAD TO TAKE PHACO OUT OF PATIENT`S EYE. AS A RESULT OF THIS EVENT, THERE WAS A TEAR IN THE POSTERIOR CAPSULE. ACCORDING TO THE SURGEON, IT APPEARS AS THOUGH A PART FROM THE INSIDE OF THE CUTTER IS WHAT BROKE OFF, INTERNALLY FROM THE TIP. THE SURGEON WIL BE SEEING THE PATIENT IN A FEW WEEKS, ONLY THEN WILL HE KNOW HOW THE PATIENT WAS AFFECTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7638183 ↗

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.