Alcon 8065751586Recalls & reported problems
Alcon Laboratories, Inc. · 25 Ga Valved Trocar Cannula Entry System, 1 ct · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380657515868), received between Mar 5, 2024 and Feb 26, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt2
- Fitting Problem1
- Leak/Splash1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE SURGERY, THE TIP OF THE OPHTHALMIC ENTRY SYSTEM WAS DEFORMED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452012 ↗MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT AN OPHTHALMIC TROCAR TIP WAS FOUND BENT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH A NEW ONE. SURGERY DETAILS WERE NOT PROVIDED, NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21100773 ↗MalfunctionJul 1, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT VITRECTOMY COMBINATION SURGERY, AN OPHTHALMIC TROCAR COULD NOT BE CUTTING. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WERE NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19642355 ↗MalfunctionMar 5, 2024Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem
ADDITIONAL INFORMATION RECEIVED STATING OPHTHALMIC TROCAR BEGAN TO LEAK AS SOON AS IT WAS INSERTED IN THE PATIENTS EYE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18838050 ↗
Other Unit, phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 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 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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