Alcon, Intrepid 8065752145Recalls & reported problems
Alcon Laboratories, Inc. · Alcon Intrepid 0.3mm Polymer I/A Coaxial Conical Angled · Class 2
All models of Alcon, Intrepid (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380657521456), received between Aug 31, 2021 and Nov 20, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (7 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
- Complete Blockage7
- Break4
- Decrease in Suction4
- Suction Failure3
- Obstruction of Flow1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT DURING SURGERY, OPHTHALMIC IRRIGATION/ASPIRATION (I/A) HANDPIECE DID NOT REACH FULL VACUUM. THE PROCEDURE DETAILS ARE UNKNOWN. THE SURGERY WAS ABLE TO COMPLETE ON THE SAME DAY. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23603096 ↗MalfunctionOct 30, 2025Break; Break
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY, WHILE DISCONNECTING THE ATTACHED TUBING, ONE OF THE OPHTHALMIC HANDPIECE TIPS BROKE OFF AND REMAINED STUCK ON THE TUBING CONNECTOR. THE SURGERY WAS COMPLETED THE SAME DAY BY REPLACING THE HANDPIECE, WITH SOME DELAY, AND THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425209 ↗MalfunctionApr 23, 2025Break; Break
A CUSTOMER REPORTED THAT THE TIPS OF TWO OPHTHALMIC HANDPIECES WERE SEPARATED FROM HUB WHICH WAS FOUND BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. SURGERY WAS COMPLETED AFTER REPLACING HANDPIECE WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21889835 ↗MalfunctionApr 22, 2025Break; Break
A NURSE REPORTED THAT DURING CATARACT SURGERY, LOOSE TIP SYSTEM MESSAGE WAS DISPLAYED WHILE USING AN OPHTHALMIC TIP. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING HANDPIECE. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21881129 ↗MalfunctionMar 10, 2025Suction Failure; Suction Failure
A NURSE REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE FAILED TO REACH FULL VACUUM IN THE IRRIGATION ASPIRATION MODE DURING THE VISCOELASTIC REMOVAL STEP, EVEN THOUGH THE SURGEON HAD THE FOOT PEDAL FULLY PRESSED. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE. THIS REPORT IS PERTAINING TO FOUR OF FOUR REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 21558370 ↗MalfunctionMar 10, 2025Decrease in Suction; Decrease in Suction
A NURSE REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE FAILED TO REACH FULL VACUUM IN THE IRRIGATION ASPIRATION MODE DURING THE VISCOELASTIC REMOVAL STEP, EVEN THOUGH THE SURGEON HAD THE FOOT PEDAL FULLY PRESSED. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE. THIS REPORT IS PERTAINING TO THREE OF FOUR REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 21557792 ↗MalfunctionMar 10, 2025Decrease in Suction; Decrease in Suction
A NURSE REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE FAILED TO REACH FULL VACUUM IN THE IRRIGATION ASPIRATION MODE DURING THE VISCOELASTIC REMOVAL STEP, EVEN THOUGH THE SURGEON HAD THE FOOT PEDAL FULLY PRESSED. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE. THIS REPORT IS PERTAINING TO ONE OF FOUR REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 21557395 ↗MalfunctionMar 4, 2025Decrease in Suction; Decrease in Suction
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 21511932 ↗MalfunctionNov 22, 2024Complete Blockage; Complete Blockage
A PHARMACIST REPORTED THAT BEFORE SURGERY CANNULA OF AN OPHTHALMIC HANDPIECE WAS CLOGGED AT THE TIME OF BLISTER OPENING. CANNULA WAS UNCLOGGED WITH BALANCED SALT SOLUTION (BSS) AND SYRINGE. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758294 ↗MalfunctionOct 27, 2024Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC HANDPIECE WAS CLOGGED. SURGERY WAS COMPLETED ON THE SAME DAY BY UNCLOGGING MANUALLY. PATIENT HARM WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541598 ↗MalfunctionAug 23, 2024Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT DURING SURGERY, SEVERAL OPHTHALMIC HANDPIECE WAS CLOGGED. SURGEON USED A SYRINGE WITH WATER TO UNBLOCK CLOG. SURGERY WAS COMPLETED AND NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING THE TWO OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20047505 ↗MalfunctionAug 22, 2024Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC HANDPIECE WAS CLOGGED. SURGEON USED A SYRINGE WITH WATER TO UNBLOCK CLOG. SURGERY WAS COMPLETED ON THE SAME DAY AND NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20037776 ↗MalfunctionJul 15, 2024Decrease in Suction; Decrease in Suction
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE EXHIBITED POOR ASPIRATION. SURGERY WAS COMPLETED WITH AN ALTERNATIVE HANDPIECE AND WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19738734 ↗MalfunctionMay 20, 2024Complete Blockage; Complete Blockage
A CUSTOMER REPORTED THAT BEFORE A SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS CLOGGED. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 19349868 ↗MalfunctionMay 16, 2024Complete Blockage; Complete Blockage
A CUSTOMER REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION WAS CLOGGED. PATIENT AND PROCEDURE WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 19329307 ↗MalfunctionFeb 26, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT AN OPHTHALMIC DISPOSABLE IRRIGATION ASPIRATION ANGLE FAILED TO ASPIRATE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18776610 ↗MalfunctionNov 20, 2023Complete Blockage; Complete Blockage
A PHARMACIST REPORTED THAT BEFORE THE CATARACT SURGERY AN OPHTHALMIC OPERATING IRRIGATION AND ASPIRATION CANNULA WAS CLOGGED. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE PRODUCT AND PATIENT HARM WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18168208 ↗MalfunctionNov 14, 2023Obstruction of Flow; Obstruction of Flow
A CUSTOMER REPORTED THAT AN OPHTHALMIC SUCTION CANNULA WAS CLOGGED BEFORE USE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129268 ↗MalfunctionAug 31, 2021Break; Break
A NURSE REPORTED THAT IN A CATARACT SURGERY DURING IRRIGATION/ASPIRATION (I/A) TIP OF THE I/A OF HANDPIECE WAS FOUND TO BE BROKEN. THE SURGERY WAS COMPLETED BY USING ALTERNATE I/A TIP WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12394576 ↗
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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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