WHITESTAR SIGNATURE NGP680702Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474534667), received between Aug 19, 2017 and Aug 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

• InjuryAug 26, 2019Electrical /Electronic Property Problem; Free or Unrestricted Flow; Electrical /Electronic Property Problem; Free or Unrestricted Flow

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A SHORT INTERRUPTION RESULTING IN A VITRECTOMY SURGICAL PROCEDURE. IT WAS REPORTED THAT PHACO MACHINE HAD UNEXPECTED CONTINUOUS IRRIGATION. AFTER THE VITRECTOMY WAS PERFORMED THE CATARACT SURGERY WAS FINISHED SUCCESSFULLY AND THE PATIENT¿S OUTCOME IS GOOD. THE SURGERY CENTER DID NOT SUSPECT THE J&J SYSTEM CAUSED THE VITRECTOMY TO OCCUR. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR THE FOOTPEDAL ACCESSORY. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.

  Patient problems: Vitrectomy

  MAUDE report 8930461 ↗
• InjuryAug 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING CATARACT PROCEDURE THE FOOTPEDAL SENT BACK THE CONTENT TO THE EYE, THERE WAS NO VACUUM, AND THE SYSTEM DID NOT RESPOND. ACCOUNT MENTIONED THAT WHEN PRESSING THE FOOTPEDAL THE SYSTEM WORKS INTERMITTENTLY WITH VACUUM AND PHACO. PATIENT PRESENTED WITH DIFFUSED CORNEAL EDEMA POST TREATMENT AND SECONDARY SURGICAL OR MEDICAL INTERVENTION IS PENDING PATIENT PROGNOSIS. THE PROCEDURE WAS DELAYED FOR 45 MINUTES FOR THIS PATIENT. VISUAL ACUITY PRE-OPERATIVE: 0,05 VISUAL ACUITY POST-OPERATIVE: ABLE TO COUNT FINGERS AT 20CM THIS REPORT IS FOR THE FOOTPEDAL. A SEPARATE REPORT IS BEING SUBMITTED FOR THE SIGNATURE PHACO SYSTEM PRODUCT.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 6806224 ↗