Featherlight micro Phaco emulsification/fragmentation handpiece. 3002.MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872008899), received between Jun 4, 2018 and Jul 9, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Property Issue” (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.

• InjuryJul 9, 2018Overheating of Device; Power Problem

  REPORTED BY SALES, WHO COLLECTED THE HAND PIECE AT THE CUSTOMER: TODAY THE LEADING NURSE, COMPLAINED ABOUT THIS ULTRASONIC HANDPIECE. VERY BAD SITUATION. AFTER A FEW SECONDS THE HANDPIECE BECOME EXTREMELY HOT WITH COMPLETELY MISSING PHACO POWER. THE SURGEON REPORTED THIS IS A VERY BAD SITUATION, HE HAD DESCEMET FOLDS, AND THE EYES LOOK NOT REALLY GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669825 ↗
• MalfunctionJun 4, 2018Physical Property Issue; Physical Property Issue

  THE COMPLAINANT STATED THAT THE CASE STARTED IN VACUUM MODE AND THE CUTTER FUNCTIONED PROPERLY. AFTER SWITCHING TO FLOW MODE, AIR BUBBLES WOULD COME OUT OF THE CUTTER TIP WHEN THE FOOT PEDAL WAS ENGAGED. THIS CONTINUED UPON SWITCHING BACK TO VACUUM MODE. THE AIR BUBBLES WERE PARTICULARLY LARGE. THE CONNECTIONS WERE CHECKED FOR TIGHTNESS, AND THE CUTTER WAS TESTED IN A CUP OF BSS, AND THE BUBBLES CONTINUES. THE CUTTER WAS THEN REPLACED AND THE CASE WAS FINISHED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY. THE CUTTER IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566163 ↗
• InjuryJun 4, 2018Material Separation; Physical Property Issue; Material Separation; Physical Property Issue

  WE RECEIVED THIS PHAKO HANDPIECE FROM OUR CUSTOMER WHO REPORTED THAT DURING A SURGERY CAME LITTLE METAL SPLINTERS IN THE EYE. ALL INFORMATION HAS BEEN DISCLOSED. THE SAMPLE IS AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION AS TO THE STATUS OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7565525 ↗

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.