Alcon, Intrepid 8065751511Recalls & reported problems
Alcon Laboratories, Inc. · Alcon Intrepid Angled 0.3mm Polymer I/A Tip · Class 2
Quick summary
This Alcon Intrepid angled tip is used for irrigation and aspiration during cataract surgery. The 46 reports mostly describe tips with sharp edges, breaking or snapping off, bending, or becoming clogged so flow stopped during surgery. 22 reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00380657515110), received between May 26, 2021 and Jul 3, 2026 — classified as 22 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (13 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
- Sharp Edges13
- Break11
- Adverse Event Without Identified Device or Use Problem7
- Material Twisted/Bent5
- Complete Blockage3
- Detachment of Device or Device Component2
- Loose or Intermittent Connection2
- Decrease in Suction1
Patient problems
- Capsular Bag Tear19
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information12
- Toxic Anterior Segment Syndrome (TASS)3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Conjunctivitis1
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Break
A CUSTOMER REPORTED THAT, TWO OPHTHALMIC IRRIGATION AND ASPIRATION TIPS WERE BROKEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT PERTAINS TO SECOND OF TWO REPORTS RECEIVED FROM THE SAME LOT NUMBER.
Patient problems: Insufficient Information
MAUDE report 25706738 ↗MalfunctionJun 25, 2026Break
A CUSTOMER REPORTED THAT, BEFORE CATARACT SURGERY, THE OPHTHALMIC TIP BROKE OFF INTO THE HANDPIECE DURING ASSEMBLY. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER TIP, AND THERE WAS NO PATIENT CONTACT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25619599 ↗MalfunctionMar 23, 2026Break; Intermittent Infusion
A PHYSICIAN REPORTED THAT DURING SURGERY, THE IRRIGATION FLOW RATE IN THE OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS UNUSUAL, AND THE TIP WAS REMOVED FROM THE EYE. THE TIP CAME OFF WHILE THE SLEEVE POSITION WAS BEING ADJUSTED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE TIP AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662060 ↗InjuryMar 12, 2026Sharp Edges
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC TIP HAS A BUR ON THE END OF THE TIP THAT CAUSED A TEAR IN POSTERIOR CAPSULE AND RESULTED IN VITRECTOMY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Capsular Bag Tear
MAUDE report 24577857 ↗MalfunctionFeb 6, 2026Obstruction of Flow; Device Contamination with Chemical or Other Material
A CUSTOMER REPORTED THAT, DURING SURGERY FOREIGN MATERIAL WAS FOUND STUCK TO IRRIGATION/ ASPIRATION (I/A) TIP. PROCEDURE DETAILS AND SURGERY COMPLETION DETAILS ARE UNKNOWN. INFORMATION REGARDING PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24277790 ↗MalfunctionAug 22, 2025Material Twisted/Bent; Material Twisted/Bent
A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP APPEARED TO HAVE AN UNUSUAL BEND. PROCEDURE DETAILS AND ANY ASSOCIATED PATIENT IMPACT WERE NOT PROVIDED. ALTHOUGH ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 22871082 ↗MalfunctionAug 13, 2025Break; Break
A PHYSICIAN REPORTED THAT THE TIP OF THE POLYMER IRRIGATION AND ASPIRATION TIP CAME OFF BEFORE SURGERY. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22796734 ↗MalfunctionJul 16, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT AN OPHTHALMIC TIP WAS FOUND TO BE BENT BEFORE CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518769 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATED THAT THE MOST RECENT CHART NOTE WAS FROM A NINE-DAY POSTOPERATIVE VISIT FOLLOWING INTRAOCULAR LENS (IOL) REPOSITIONING. THE BLURRINESS HAD IMPROVED, ALTHOUGH THE VISION REMAINED SOMEWHAT BLURRY. HOWEVER, THE GENERAL POSTOPERATIVE APPEARANCE WAS GOOD, WITH NO SIGNS OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS ADVISED TO RETURN FOR SERIAL REFRACTIONS AT FUTURE VISITS.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s); Toxic Anterior Segment Syndrome (TASS)
MAUDE report 22459869 ↗MalfunctionMay 30, 2025Break; Fitting Problem; Break; Fitting Problem
A PHARMACIST REPORTED THAT AN OPHTHALMIC TIP BROKEN WHEN SCREWING TIP TO THE HANDPIECE AND PART OF THE TIP STUCK ON HANDPIECE AT THE UNKNOWN TIMEFRAME OF CATARACT SURGERY. PROCEDURE COMPLETION DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22112863 ↗MalfunctionMar 20, 2025Break; Break
A PHARMACIST REPORTED THAT BEFORE CATARACT SURGERY AN INTREPID IRRIGATION AND ASPIRATION TIP OF THE CENTURION CASSETTE PACK WAS BROKEN WHEN OPENED. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21649832 ↗MalfunctionDec 12, 2024Break; Break
A CUSTOMER REPORTED THAT FIVE OPHTHALMIC TIPS BROKE OFF FROM THE HANDPIECE. 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 20912114 ↗MalfunctionNov 19, 2024Complete Blockage; Complete Blockage
A PHYSICIAN REPORTED THAT DURING SURGERY, OPHTHALMIC TIP WAS BLOCKED. SURGERY WAS COMPLETED. SURGERY WAS COMPLETED WITH AN ALTERNATIVE TIP AND WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20723478 ↗MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT DURING THE PREPARATION OF THE PROCEDURE AN OPHTHALMIC POLYMER TIP WAS OPENED FOR ASSEMBLY AND IT CAME WITHOUT THE POLYMER TIP. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555089 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC TIPS HAS ROUGH OR SHARP EDGES AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS RECORD IS REGARDING TO PATIENT ONE OF FOUR PATIENTS FROM THE INITIAL REPORTER.
Patient problems: Capsular Bag Tear
MAUDE report 20214030 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC TIPS HAS ROUGH OR SHARP EDGES AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS RECORD IS REGARDING TO PATIENT ONE OF FOUR PATIENTS FROM THE INITIAL REPORTER.
Patient problems: Capsular Bag Tear
MAUDE report 20213977 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION TIP WERE NOT SMOOTH AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS RECORD IS REGARDING TO PATIENT THREE OF FOUR PATIENTS FROM THE INITIAL REPORTER.
Patient problems: Capsular Bag Tear
MAUDE report 20213426 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION TIP WERE NOT SMOOTH AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS RECORD IS REGARDING TO PATIENT THREE OF FOUR PATIENTS FROM THE INITIAL REPORTER.
Patient problems: Capsular Bag Tear
MAUDE report 20213377 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION TIP WERE NOT SMOOTH AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS RECORD IS REGARDING TO PATIENT THREE OF FOUR PATIENTS FROM THE INITIAL REPORTER.
Patient problems: Capsular Bag Tear
MAUDE report 20213184 ↗InjurySep 13, 2024Sharp Edges; Sharp Edges
A NURSE REPORTED THAT OPHTHALMIC IRRIGATION AND ASPIRATION TIP HAS ISSUES AND CAUSING ANTERIOR CAPSULAR RENTS. PATIENT AND PROCEDURE DETAIL WERE NOT REPORTED. PATIENT SYMPTOMS WERE IMPROVING.
Patient problems: Capsular Bag Tear
MAUDE report 20211802 ↗MalfunctionJul 18, 2024Complete Blockage; Complete Blockage
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND TO BE BLOCKED. CATARACT SURGERY WAS SCHEDULED. DETAILS OF PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19768422 ↗InjuryJun 26, 2024Sharp Edges; Sharp Edges
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP CAPSULE TORE WHILE GENTLE POLISHING. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 19614262 ↗InjuryJun 26, 2024Sharp Edges; Sharp Edges
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP WAS TORE AND UPON EXAMINING TIP THERE WAS A RIDGE ALONG THE HEAD OF THE TIP LOOKED LIKE A MINI-SAW. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 19613934 ↗InjuryJun 26, 2024Sharp Edges; Sharp Edges
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP CAPSULE TORE WHILE POLISHING. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 19613809 ↗MalfunctionMay 21, 2024Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP FOUND TWISTED. 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 19359296 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.