Synergetics 20.04.25SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20841305108848), received between Nov 30, 2022 and May 16, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Particulates; Particulates

  THE USER FACILITY REPORTED DURING A RETINA CASE THE PRODUCT WAS LEAVING DIAMOND DUST BEHIND. THEY DISCONTINUED USING THE MEMBRANE SCRAPPER. ANOTHER MEMBRANE SCRAPPER WAS OPENED ON THE FIELD AND USED WITHOUT ANY ISSUES. THE DOCTOR LATER REPORTED THE DIAMOND DUST WAS REMOVED WITH VITRECTOR AND SOFT TIP EXTRUSION CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034235 ↗
• MalfunctionJan 22, 2025Particulates; Particulates

  THE USER FACILITY REPORTED THERE WAS SOME DUST IN THE EYE OF THE RETINA PEEL CASES. THE SURGICAL TEAM WAS NOT SURE IF IT COULD HAVE COME FROM THE INSTRUMENT. THE SURGEON WAS ABLE TO ASPIRATE THE DUST OUT AND FOLLOW UP SHOWED NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208083 ↗
• InjuryNov 7, 2023Break; Break

  THE USER FACILITY REPORTED A 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPPER (DDMS) TIP BROKE OFF INSIDE PATIENT''S RIGHT EYE. THE SURGEON COULD NOT REMOVE IT THROUGH THE 25GA CANNULA. THE CANNULA WAS REMOVED, THE CONJUNCTIVA WAS OPENED WITH WESTCOTT, AND A 20GA SCLERA INCISION WAS MADE WITH AN MICRO VITREORETINAL (MVR) BLADE. THE TIP WAS REMOVED USING INTERNAL LIMITING MEMBRANE (ILM) FORCEPS. THE INCISION WAS CLOSED WITH 7-0 VICRYL SUTURE. CLOSED CONJUNCTIVA WITH 6-0 PLAIN GUT SUTURE.

  Patient problems: Eye Injury

  MAUDE report 18086294 ↗
• InjuryJul 26, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DIAMOND DUSTED MEMBRANE SCRAPER BROKE OFF AT THE HUB INTO THE BACK OF THE PATIENT''S EYE AND INJURED THE RETINA (AFTER IT BROKE OFF OF HANDLE) CAUSING MICROSCOPIC TEARING. THE SURGEON REMOVED THE TIP FROM THE EYE, AND LASERED THE BACK OF THE EYE WHERE THE DIAMOND DUSTED TIP HIT. THE SURGERY WAS PROLONGED AN ADDITIONAL THREE MINUTES. THE PATIENT IS DOING WELL AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400442 ↗
• MalfunctionNov 30, 2022Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT TWO DIAMOND DUSTED MEMBRANE SCRAPERS BROKE DURING THE SAME SURGERY. ONE BROKE AT THE TIP BUT WAS NOT IN THE PATIENT''S EYE. THE PHYSICIAN USED A SECOND ONE AND THE TIP BROKE OFF AT THE INSERTION TO THE HANDLE WHILE IN THE PATIENT''S EYE. THE PHYSICIAN USED A MOSQUITO CLAMP TO PULL THE TIP OUT OF THE TROCAR. AN ALCON 25G VALVE CANNULA WAS USED. THE INCISION WAS NOT ENLARGED. THE 8-0 VICTYL SUTURE REQUIRED WAS PART OF THE SURGICAL PROTOCOL AND NOT CAUSED BY THE BROKEN SCRAPER. THE SURGEON FINISHED THE SURGERY WITH ANOTHER SCRAPER. THERE WAS NO DAMAGE TO THE EYE, COMPLICATIONS OR INJURIES TO THE PATIENT. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888360 ↗