Alcon, Intrepid 8065751512Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380657515127), received between Jan 18, 2022 and Jun 10, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Twisted/Bent

  A CUSTOMER REPORTED THAT BEFORE THE CATARACT SURGERY THE IRRIGATION AND ASPIRATION TIPS WERE FOUND TO BE BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT WITHOUT ANY PATIENT CONTACT AND HEALTH IMPACT. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455922 ↗
• MalfunctionMar 21, 2026Suction Failure

  A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC TIP EXHIBITED POOR ASPIRATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED WITH ANOTHER ONE, AND THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656947 ↗
• MalfunctionFeb 12, 2026Break

  A NURSE REPORTED THAT DURING CATARACT SURGERY IRRIGATION AND ASPIRATION (I/A) TIP POLYMER PROTECTOR ON THE FRONT WAS MISSING. PROCEDURE WAS COMPLETED BY USING ANOTHER I/A TIP. PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24321023 ↗
• MalfunctionFeb 12, 2026Break

  A CUSTOMER REPORTED THAT THE THREADED TOP OF THE OPHTHALMIC IRRIGATION¿ASPIRATION TIP BROKE INTO TWO PIECES. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24320320 ↗
• MalfunctionOct 31, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT AN OPTHALMIC IRRIGATION AND ASPIRATION TIP WOULD NOT EXHIBIT THE SUCTION FUNCTION DURING THE CATARACT SURGERY. DETAILS OF THE PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23438538 ↗
• MalfunctionJun 13, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE OPHTHALMIC SURGERY, OPHTHALMIC IRRIGATION AND ASPIRATION TIP COULD NOT BE USED ON A PATIENT PLANNED ONLY IA OPERATION DUE TO IA ASPIRATION FAILURE. THE SURGERY WAS COMPLETED AFTER REPLACING THE WHOLE SET WITH ANOTHER ONE. THE SAMPLE WAS NOT AVAILABLE BECAUSE IT WAS USED ON A PATIENT WITH AN INFECTION AND DISCARDED. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202350 ↗
• MalfunctionMar 4, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING SURGERY, THE OPHTHALMIC IRRIGATION ASPIRATION TIP WAS DEFORMED AND THE ASPIRATION WAS POOR. THE SURGERY WAS COMPLETED BY USING NEW IRRIGATION AND ASPIRATION TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512701 ↗
• MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE TIP AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457603 ↗
• MalfunctionDec 9, 2024Adverse Event Without Identified Device or Use Problem; Sharp Edges; Adverse Event Without Identified Device or Use Problem; Sharp Edges

  A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP WAS USED TO PERFORM A SURGERY. THE PATIENT EXPERIENCED TEAR IN THE CAPSULE. THE SURGERY WAS COMPLETED. PROCEDURE DETAILS WAS NOT REPORTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20879392 ↗
• MalfunctionOct 14, 2024Break; Break

  A NURSE REPORTED THAT DURING CATARACT SURGERY, FOUR OF OPHTHALMIC TIPS BROKE OUTSIDE THE EYE AT THE END OF CASE. SURGERY WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437862 ↗
• MalfunctionSep 23, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT IN AN IRRIGATION AND ASPIRATION TIP EXHIBITED ASPIRATION FAILURE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED. PROCEDURE DETAILS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277764 ↗
• MalfunctionSep 12, 2024Break; Break

  A PHYSICIAN REPORTED THAT DURING PRE-SURGERY SETUP IRRIGATION AND ASPIRATION TIP WAS NOT ATTACHED WHEN OPENED. IT WAS ALSO REPORTED THAT IT WAS CHECKED INSIDE THE CASE, BUT IT DID NOT SEEM TO HAVE FALLEN OFF. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201640 ↗
• MalfunctionJul 30, 2024Break; Break

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY IT WAS FOUND THAT AN OPHTHALMIC TIP FOUND BROKEN AND WAS REMAINED INSIDE. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19862861 ↗
• MalfunctionJun 13, 2024Break; Break

  A NURSE REPORTED THAT DURING CATARACT SURGERY MANY OPHTHALMIC TIPS BROKE OFF. SURGERY WAS COMPLETED WITH USING AN ALTERATIVE PRODUCT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526333 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND TO BE TWISTED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458267 ↗
• MalfunctionMay 15, 2024Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING IRRIGATION AND ASPIRATION TIP WAS BROKEN. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318177 ↗
• MalfunctionApr 24, 2024Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING IRRIGATION AND ASPIRATION TIP HOLE WAS NOT OPENED AND NO ASPIRATION DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172475 ↗
• MalfunctionMar 25, 2024Suction Problem; Connection Problem; Suction Problem; Connection Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION WAS NOT APPLIED AT ALL DURING USE OF IRRIGATION ASPIRATION TIP FROM THE BEGINNING OF THE SURGERY, THAT THE THREADED PART OF THE IRRIGATION ASPIRATION HANDPIECE CONNECTION OF THE POLYMER IRRIGATION ASPIRATION TIP WAS DAMAGED. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968327 ↗
• MalfunctionMar 20, 2024Connection Problem; Connection Problem

  A PHYSICIAN REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION TIP CONNECTION FAILURE OCCURRED DURING TEST. THE CATARACT SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.

  Patient problems: Insufficient Information

  MAUDE report 18939309 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC IRRIGATION ASPIRATION TIPS COMPROMISED THE CAPSULE DURING POLISH MODE OF PHACOEMULSIFICATION AND THE SURGERY WAS COMPLETED. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Rupture

  MAUDE report 18893393 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC IRRIGATION ASPIRATION TIPS COMPROMISED THE CAPSULE DURING POLISH MODE OF PHACOEMULSIFICATION. SURGERY WAS COMPLETED BY IMPLANTING A THREE PIECE LENS INSTEAD OF THE INITIALLY PLANNED LENS. THIS COMPLAINT IS PERTAINING THE TWO OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Rupture

  MAUDE report 18863980 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY AN OPHTHALMIC TIP WAS ABNORMALLY BENT. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709912 ↗
• InjuryNov 14, 2023Sharp Edges; Sharp Edges

  A CUSTOMER REPORTED THAT A SEVENTY FIVE YEARS OLD FEMALE PATIENT, WHILE USING AN OPHTHALMIC TIP DURING A PHACO/INTRA OCULAR LENS (IOL) SURGERY WHEN POLISHING THE POSTERIOR CAPSULE AFTER CORTEX REMOVAL A CAPSULE TEAR OCCURRED AS THE TIP HAD SHARP EDGES. THE SURGERY WAS COMPLETED BY PERFORMING AN ANTERIOR VITRECTOMY AND A SULCUS LENS WAS PLACED. THERE WAS NO PATIENT HARM.

  Patient problems: Capsular Bag Tear

  MAUDE report 18129057 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT PATIENT DID NOT EXPERIENCED CORNEAL BURN. NUMBER OF PATIENTS INVOLVED IS 15.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 18011858 ↗
• MalfunctionOct 4, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING A SURGERY WHILE USING AN OPHTHALMIC TIP THE SHAFT WAS FOUND BENT WHEN IT WAS OPENED AND CONNECTED TO THE IRRIGATION AND ASPIRATION HANDPIECE. HE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867691 ↗