Synergetics 58.20-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841305101699), received between Oct 19, 2023 and Oct 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryOct 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-STEP SUTURELESS CANNULA FAILED DURING SURGERY. WHEN THE SURGEON ATTEMPTED TO REMOVE THE TROCAR AT THE END OF THE PROCEDURE, THE TOP OF THE TROCAR BROKE OFF LEAVING THE CANNULA IN THE EYE. THE SURGEON HAD TO GO BACK INTO THE EYE AND RETRIEVE THE CANNULA PART OF THE TROCAR THAT FELL DOWN ONTO THE RETINA. A 20GA INCISION WAS MADE TO ENLARGE THE INCISION USING A V-LANCE BLADE. AFTER SEVERAL ATTEMPTS OF TRYING TO RETRIEVE THE CANNULA WITH DIFFERENT TYPES OF FORCEPS, THE SURGEON DECIDED TO USE A CHANDELIER LIGHT FIBER SO THAT TWO FORCEPS COULD BE USED TO GRASP THE CANNULA. THE CANNULA WAS THEN REMOVED FROM THE BACK OF THE EYE. INCISION WAS ENLARGED, BUT NO SUTURES WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969750 ↗