WHITESTAR PHACO HANDPIECE 690697Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474508040), received between Sep 25, 2017 and Oct 5, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 reports).

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

• InjuryOct 5, 2018Accessory Incompatible; Increase in Suction; Accessory Incompatible; Increase in Suction

  DURING A CATARACT PROCEDURE, A CAPSULAR RUPTURE OCCURRED ON THE RIGHT OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE AND AN INCISION ENLARGEMENT. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE SURGERY, THE PHACO HANDPIECE HAD SLOW ASPIRATION AT FIRST AND SUDDENLY THE ASPIRATION BECAME TOO AGGRESSIVE. THE PROCEDURE WAS COMPLETED AND THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE SULCUS WITH OPTIC CAPTURE. THE PATIENT OUTCOME IS EXPECTED GOOD.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7939019 ↗
• MalfunctionJun 1, 2018Temperature Problem; Temperature Problem

  THE ACCOUNT REPORTED THAT HANDPIECE BECAME TOO HOT. THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVENT AND NO PATIENT TREATMENTS DELAYED OR CANCELLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7561614 ↗
• MalfunctionJun 1, 2018Temperature Problem; Temperature Problem

  THE ACCOUNT REPORTED THAT THE HANDPIECE WOULD NOT TUNE AND BECAME TOO HOT. THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVENT AND NO PATIENT TREATMENTS DELAYED OR CANCELLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7561573 ↗
• MalfunctionSep 25, 2017Temperature Problem; Temperature Problem

  THE ACCOUNT REPORTED THAT HANDPIECE BECAME TOO HOT DURING TUNE AND SURGERY. THEY CHECKED WITH DEMO HANDPIECE IT WAS WORKING FINE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVENT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6889458 ↗