INTREPID® 8065751013Recalls & reported problems
Alcon Laboratories, Inc. · INTREPID® Micro-Coaxial I/A tip, 0.3 mm, Bent · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657510139), received between Mar 24, 2022 and Oct 31, 2025 — classified as 3 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Suction Problem3
- Complete Blockage2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
- Rupture1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY TIP WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437443 ↗MalfunctionSep 13, 2024Break; Break
A GOVERNMENT AGENCY REPORTED THAT AFTER THE COMPLETION OF THE CATARACT SURGERY THE PHACOEMULSIFICATION IRRIGATION AND ASPIRATION HANDPIECE ACCIDENTALLY FELL ON THE GROUND AND THE NEEDLE HAD BROKEN AND COULD NOT BE USED FURTHER.
Patient problems: Insufficient Information
MAUDE report 20210789 ↗MalfunctionMar 21, 2024Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIPS WERE FOUND TO BE POORLY ALIGNED AND DIFFICULT TO ASPIRATE. THE DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM. SURGERY WAS COMPLETED WITH ALTERNATIVE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18948119 ↗MalfunctionFeb 2, 2024Suction Problem; Suction Problem
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP EXHIBITED ASPIRATION FAILURE. PROCEDURE DETAILS WAS NOT PROVIDED AND THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629117 ↗MalfunctionDec 25, 2023Break; Break
A PHYSICIAN REPORTED THAT WHEN INSTALLING THE IRRIGATION ASPIRATION TIP, IT WAS BROKEN FROM THE ROOT. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18390630 ↗MalfunctionOct 24, 2023Suction Problem; Defective Component; Suction Problem; Defective Component
A PHYSICIAN REPORTED THAT OPHTHALMIC OPERATING TIPS MOUTH IS TRANSVERSE AND NOT LOCATED IN THE ELBOW PART, IT WAS DIFFICULT TO ASPIRATE BEFORE STARTING THE SURGERY. THE PATIENT IMPACT DETAILS WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995323 ↗MalfunctionOct 5, 2023Break; Break
A PHYSICIAN REPORTED OPHTHALMIC ASPIRATION TIP WAS BROKEN DURING SURGERY. THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17883257 ↗InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY CAPSULAR RUPTURE AND BURR ON THE OPHTHALMIC TIP WAS OBSERVED. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Rupture
MAUDE report 16119931 ↗InjuryMar 24, 2022Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY TIP WAS CONTINUOUSLY SHOWING OCCLUSION AND PATIENT EXPERIENCED WITH MILD DESCEMET MEMBRANE DETACHMENT. THE PROCEDURE WAS COMPLETED BY MANUAL IRRIGATION AND ASPIRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13885275 ↗InjuryMar 24, 2022Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY TIP WAS CONTINUOUSLY SHOWING OCCLUSION AND PATIENT EXPERIENCED WITH MILD DESCEMET MEMBRANE DETACHMENT. THE PROCEDURE WAS COMPLETED BY MANUAL IRRIGATION AND ASPIRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13885141 ↗
Other NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED devices
- ULTRA FLOW 8065751795Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED22 reports
- INTREPID® 8065751012Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED8 reports
- ALCON 8065740970Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED3 reports
- ULTRA FLOW 00380658170011Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED2 reports
- ALCON 8065740969Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.