Synergetics 56.21.25PSRecalls & reported problems
Synergetics USA, Inc. · Stiff 25ga Wide Field Endo Illuminator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20841305107322), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A USER FACILITY REPORTED THAT WHILE UTILIZING A SYNERGETICS LIGHT PROBE ON A CONSTELLATION, THE FIBER OPTIC CABLE SEPARATED FROM THE METAL SHEATH. THE SHEATH STAYED IN THE TROCAR AND DID NOT TOUCH THE RETINA. THE PIECE THAT BROKE OFF WAS REMOVED WITH A FORCEPS FROM THE PATIENT'S EYE WITHOUT HARM. THE SURGERY WAS DELAYED FOR 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19624216 ↗
Other Endoilluminator devices
- Alcon 00380650002525Alcon Laboratories, Inc. · Endoilluminator1 recall0 reports
- Alcon 00380650002532Alcon Laboratories, Inc. · Endoilluminator1 recall0 reports
- Synergetics 56.34.25PSynergetics USA, Inc. · Endoilluminator2 reports
- 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
- 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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