Alcon, Intrepid 8065752144Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380657521449), received between Jun 24, 2021 and Jan 8, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS CLOGGED BEFORE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016590 ↗
• MalfunctionSep 19, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC DISPOSABLE TIP WAS BENT WHEN OPENED BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23093998 ↗
• MalfunctionJul 30, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE SOLUTION DID NOT COME OUT FROM OPHTHALMIC IRRIGATION ASPIRATION TIP BECAUSE OF BLOCKAGE DURING THE CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666396 ↗
• MalfunctionJun 11, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SURGICAL IRRIGATION AND ASPIRATION TIP WAS FOUND TO BE BENT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19508651 ↗
• MalfunctionApr 19, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC HANDPIECE TIP WAS FOUND TO BENT DURING THE SETTING BEFORE SURGERY. THE SURGERY WAS COMPLETED BY USING THE ALTERNATIVE PRODUCT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143659 ↗
• MalfunctionMar 25, 2024Material Twisted/Bent; Material Twisted/Bent

  THE PHYSICIAN REPORTED THAT AN OPHTHALMIC SURGICAL IRRIGATION AND ASPIRATION TIP WAS FOUND BENT BEFORE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968329 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SURGICAL IRRIGATION AND ASPIRATION TIP WAS FOUND BENT DURING SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE TYPE OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766652 ↗
• MalfunctionDec 18, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING SURGERY WHILE USING A HANDPIECE, ASPIRATION FAILURE OCCURRED AT THE TIME OF IRRIGATION AND ASPIRATION. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE TYPE OF PROCEDURE WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343179 ↗
• MalfunctionNov 1, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WHILE USING A REUSABLE HANDPIECE ASPIRATION FAILURE HAD OCCURRED AT THE TIME OF IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO HARM THE PATIENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18045345 ↗
• MalfunctionOct 17, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT SURGEON HAS BEEN FOUND IRRIGATION AND ASPIRATION TIP WAS BENT BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949087 ↗
• InjuryJun 24, 2021Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING A SURGICAL PROCEDURE THE PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURE WHICH OCCURRED IN IRRIGATION/ASPIRATION (I/A) MODE. THE I/A TIP WAS VIEWED UNDER THE MICROSCOPE AND FOUND TO HAVE A BURR. THE SURGERY WAS COMPLETED WITH NO ADDITIONAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12055904 ↗