PHACOFIT OM05510116Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474500419), received between Oct 26, 2023 and Oct 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 16, 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.

• MalfunctionOct 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHACO TIP SHOWED A CROOKED EDGE. NO MEDICAL INTERVENTIONS WHERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PRODUCT WAS IN CONTACT WITH THE PATIENT'S EYE. THE PRODUCT DEFECT WAS NOTICED AFTER PATIENT CONTACT AND WAS NOT CAUSED DUE TO SHIPMENT PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 3 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012098 ↗
• MalfunctionOct 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHACO TIP HAD A BROKEN END. NO MEDICAL INTERVENTIONS WHERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PRODUCT WAS IN CONTACT WITH THE PATIENT'S EYE. THE PRODUCT DEFECT WAS NOTICED AFTER PATIENT CONTACT AND WAS NOT CAUSED DUE TO SHIPMENT PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 4 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012040 ↗
• MalfunctionOct 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHACO TIP SHOWED A CROOKED EDGE. NO MEDICAL INTERVENTIONS WHERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PRODUCT WAS IN CONTACT WITH THE PATIENT'S EYE. THE PRODUCT DEFECT WAS NOTICED AFTER PATIENT CONTACT AND WAS NOT CAUSED DUE TO SHIPMENT PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011966 ↗
• MalfunctionOct 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHACO TIP SHOWED A CROOKED EDGE. NO MEDICAL INTERVENTIONS WHERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PRODUCT WAS IN CONTACT WITH THE PATIENT'S EYE. THE PRODUCT DEFECT WAS NOTICED AFTER PATIENT CONTACT AND WAS NOT CAUSED DUE TO SHIPMENT PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011953 ↗