ALCON 00380650003539Recalls & reported problems
Alcon Laboratories, Inc. · 27G 4mm Entry System SA, 3 count · Class 1
Data updated Oct 13, 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 00380650003539), received between Sep 9, 2024 and Sep 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
A HEALTHCARE PROFESSIONAL REPORTED THAT ENTRY SYSTEM STREAMING (LEAKING) AND THEN THE LEAK EVENTUALLY STOPPED DURING THE SURGERY. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE VITREORETINAL SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167391 ↗
Other Cannula, Trocar, Ophthalmic devices
- UNITY 00380650004680Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall1 report
- ALCON 00380650003560Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650004673Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650003591Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650003584Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- MANI Trocar Kit MTK25S TROCAR KIT 25G SMani, Inc. · Cannula, trocar, ophthalmic1 recall0 reports
- High flow infusion line for 20, 23, 25 & 27G cannula system 1279.HFD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Cannula, Trocar, Ophthalmic2 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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