Alcon, Intrepid 8065752146Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657521463), received between Sep 27, 2023 and Jun 19, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT BEFORE A SURGERY AN OPHTHALMIC TIP WAS FOUND TO BE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561905 ↗
• MalfunctionFeb 20, 2026Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILED FROM THE IRRIGATION AND ASPIRATION HANDPIECE DURING SURGERY OF ULTRASOUND PHASE. PROCEDURE WAS COMPLETED ON THE SAME DAY. PATIENT IMPACT AND PROCEDURE DETAILS HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24399226 ↗
• MalfunctionFeb 18, 2026Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILED FROM THE IRRIGATION AND ASPIRATION HANDPIECE DURING SURGERY OF ULTRASOUND PHASE. PROCEDURE WAS COMPLETED ON THE SAME DAY. PATIENT IMPACT AND PROCEDURE DETAILS HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24376751 ↗
• MalfunctionSep 16, 2025Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  THE PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY THE IRRIGATION AND ASPIRATION HANDPIECE WOULD NOT INCREASING THE SUCTION PRESSURE AND IT WAS CLOGGED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062686 ↗
• MalfunctionMay 28, 2025Break; Break

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, THE TIP OF THE PRODUCT WAS BROKEN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095082 ↗
• MalfunctionJan 9, 2025Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT, THE OPHTHALMIC IRRIGATION AND ASPIRATION HANDPIECE HAS CLOGGED APPROXIMATELY THREE TIMES AND THE SURGEON FLUSHED THE DEVICE THEN IT WORKED PROPERLY. THE SURGERY WAS SLIGHTLY DELAYED, BUT THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109249 ↗
• MalfunctionSep 27, 2024Complete Blockage; Complete Blockage

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC HANDPIECE TIP WAS CLOGGED. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 20320409 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION HANDPIECE TIP WAS FOUND TWISTED IN PACKAGING. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20126504 ↗
• MalfunctionOct 24, 2023Break; Break

  A PHYSICIAN REPORTED THAT THE IRRIGATION AND ASPIRATION TIP WAS BROKE IMMEDIATELY DURING SETTING JUST BEFORE USING IT DURING A TEST. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993928 ↗
• MalfunctionSep 27, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ASPIRATION FAILED WITH OPHTHALMIC HANDPIECE DURING THE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS AN UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823482 ↗