INTREPID® 8065752885Recalls & reported problems
Alcon Laboratories, Inc. · INTREPID® Transformer IA HP · Class 1
All models of INTREPID (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon INTREPID Transformer is an irrigation and aspiration tip used in eye surgery to wash out and suction fluid from the eye. Most of the 29 reports describe the device failing to suction or build vacuum, being clogged or blocked so fluid would not flow, or tips and blue tips found bent or broken, sometimes leaving fragments in the eye. Reports mention 5 injuries and no deaths. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380657528851), received between Apr 13, 2021 and Aug 10, 2026 — classified as 5 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (10 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.
Reports received per month
Most reported problems
Device problems
- Suction Failure10
- Suction Problem6
- Break3
- Obstruction of Flow3
- Adverse Event Without Identified Device or Use Problem2
- Material Twisted/Bent2
- Particulates2
- Decrease in Suction1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information6
- Capsular Bag Tear3
- Foreign Body In Patient2
- Post Operative Wound Infection1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Break
A physician reported that the ophthalmic blue tip of the product was found to be broken during setup. No additional procedural details or information regarding patient impact were reported. Follow-up information has been requested; however, it is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192441 ↗MalfunctionJul 15, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25823682 ↗MalfunctionMar 30, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC TRANSFORMER DID NOT BUILD THE VACUUM IN THE SYSTEM. THE ISSUE WAS RESOLVED BY CHANGING THE PRODUCT CAUSING NO IMPACT ON THE PATIENT. PROCEDURE DETAILS WERE NOT REPORTED. 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 24712300 ↗MalfunctionFeb 6, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND BENT PRIOR TO SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT A PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276056 ↗MalfunctionJan 16, 2026Obstruction of Flow
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS CLOGGED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091604 ↗MalfunctionJul 25, 2025Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT OPHTHALMIC TRANSFORMER HAD NO SUCTION. 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 22607953 ↗MalfunctionMay 21, 2025Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT DURING THE SURGERY AN INTREPID TRANSFORMER COULD NOT ASPIRATE DURING IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE WITH NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059018 ↗MalfunctionApr 21, 2025Obstruction of Flow; Obstruction of Flow
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION 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 21872486 ↗MalfunctionFeb 12, 2025Suction Failure; Suction Failure
A NURSE REPORTED THAT TWO OPHTHALMIC IRRIGATION ASPIRATION HANDPIECES WOULD NOT ASPIRATE DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE HANDPIECES WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362468 ↗MalfunctionFeb 3, 2025Suction Problem; Suction Problem
THE CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION HANDPIECES WERE NOT PROVIDING ADEQUATE VACUUM. THE PROCEDURE DETAILS WERE NOT REPORTED. PATIENT IMPACT HAS NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21292487 ↗MalfunctionJan 29, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow
THE CUSTOMER REPORTED THAT DURING SURGERY SURGEON NOTICED SOMETHING BLOCKING THE PORT AND NOT ALLOWING PROPER SUCTION WHILE USING AN OPHTHALMIC IRRIGATION AND ASPIRATION TRANSFORMERS. THE PROCEDURE WAS COMPLETED BY OPENING UP NEW TRANSFORMER UNTIL ONE WAS OPENED THAT WORKED PROPERLY. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21263571 ↗MalfunctionJan 20, 2025Suction Problem; Suction Problem
A NURSE REPORTED WHEN A PATIENT WAS SCHEDULED FOR VITREORETINAL SURGERY, THE HANDPIECES WERE NOT FUNCTIONING AS EXPECTED AND WERE NOT ASPIRATING THE CATARACT. THERE WERE NO ERROR MESSAGES, OCCLUSION BELLS, OR ANY INDICATION ON THE SYSTEM. THE TIP OF ONE HANDPIECE APPEARED TO HAVE A FOREIGN BODY STUCK IN IT, THERE WAS NO PATIENT CONTACT. EACH TIME THIS ISSUE OCCURRED, THE HANDPIECE WAS REMOVED FROM THE STERILE FIELD AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURES WITHOUT CAUSING HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21189082 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT DURING SURGERY AN IRRIGATION AND ASPIRATION TIP WAS USED BUT THEY FOUND THE WOUND ON THE SECONDARY SIDE. THE SURGERY WAS COMPLETED WITHOUT CHANGING THE PRODUCT WITHOUT ANY IMPACT TO THE PATIENT.
Patient problems: Post Operative Wound Infection
MAUDE report 20532190 ↗MalfunctionAug 12, 2024Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SYSTEM EXHIBITED INFUSION PROBLEM AND RESIDUAL ASPIRATION PROBLEM DESPITE FOOTSWITCH RELEASE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19959049 ↗MalfunctionJun 7, 2024Suction Failure; Suction Failure
AN OPHTHALMOLOGIST REPORTED THAT OCCLUSION OCCURRED CONTINUOUSLY AND AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE DID NOT ASPIRATE IN THE VISCO PHASE OF CATARACT SURGERY (WITHOUT INTRA OCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER CHANGING THE CASSETTE ON THE SAME DAY. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19492837 ↗MalfunctionMay 22, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP EXHIBITED ASPIRATION FAILURE DURING SURGERY. THE SURGERY WAS CONTINUED WITH THE SAME PRODUCT. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369922 ↗MalfunctionMay 10, 2024Suction Problem; Suction Problem
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE HAD NO SUCTION. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19284158 ↗MalfunctionFeb 13, 2024Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT DURING SETUP, AN OPHTHALMIC IRRIGATION/ASPIRATION TIP EXHIBITED SUCTION FAILURE DURING SETUP. PROCEDURE WAS COMPLETED USING NEW DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18694449 ↗MalfunctionJan 1, 2024Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE HAD NO SUCTION WITH USE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER PRODUCT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423082 ↗MalfunctionDec 19, 2023Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE WOULD NOT BUILD VACUUM DURING CATARACT SURGERY. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18357363 ↗MalfunctionDec 14, 2023Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT IRRIGATION/ASPIRATION HANDPIECE WOULD NOT BUILD VACUUM DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH OTHER ONE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324300 ↗MalfunctionDec 8, 2023Suction Problem; Suction Problem
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TRANSFORMER THAT DID NOT ASPIRATE. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18298058 ↗MalfunctionNov 3, 2023Break; Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC TIP WAS FOUND TO BE BROKEN BEFORE A CATARACT SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062996 ↗MalfunctionSep 1, 2023Break; Break
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN IRRIGATION/ASPIRATION POLYMER TIP WAS BROKE OFF INTO PATIENT'S EYE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17668868 ↗InjuryOct 26, 2022Defective Device; Defective Device
A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION (I/A) HANDPIECE PRESENTED BURR AT THE END OF THE TIP DURING A SURGERY. THE PATIENT EXPERIENCED POSTERIOR CAPSULE TEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Capsular Bag Tear
MAUDE report 15673173 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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