Synergetics 56.34.25PRecalls & reported problems
Synergetics USA, Inc. · 25ga High-Flow I.I.C. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20841305107438), received between Dec 19, 2022 and Dec 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2022Break; Break
IT WAS REPORTED THE USER FACILITY HAD A MICROSCOPIC GLASS PART FALL ONTO THE POSTERIOR SEGMENT ON THE RETINA. THE SURGEON REMOVED THE LENS WITH A 25G VITRECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16009326 ↗MalfunctionDec 19, 2022Break; Break
IT WAS REPORTED THE USER FACILITY HAD A MICROSCOPIC GLASS PART FALL ONTO THE POSTERIOR SEGMENT ON THE RETINA. THE SURGEON REMOVED THE LENS WITH A 25G VITRECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16009291 ↗
Other Endoilluminator devices
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- Alcon 00380650002532Alcon Laboratories, Inc. · Endoilluminator1 recall0 reports
- Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 25G 3269.SBS05D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Endoilluminator1 report
- Synergetics 56.54.27PSynergetics USA, Inc. · Endoilluminator1 report
- Synergetics 56.21.25PSSynergetics USA, Inc. · Endoilluminator1 report
- Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 23G 3269.SBS06D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Endoilluminator1 report
- Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) 3269.MBD27D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Endoilluminator1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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