INTREPIDRecalls & reported problems across all models
Alcon Laboratories, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 3 models of INTREPID by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2021 and Aug 10, 2026 — classified as 12 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported INTREPID problems
Device problems
- Break10
- Suction Failure10
- Suction Problem9
- Obstruction of Flow4
- Adverse Event Without Identified Device or Use Problem3
- Particulates3
- Complete Blockage2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information8
- Capsular Bag Tear5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Rupture2
- Blurred Vision1
- Inflammation1
INTREPID models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTREPID® 8065752885Cannula, ophthalmic29 reports
- INTREPID® 8065751013NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED10 reports
- INTREPID® 8065751012NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED8 reports
Recent INTREPID adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174982 ↗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 ↗MalfunctionOct 31, 2025Break; Break
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY TIP WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437443 ↗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 ↗InjuryNov 18, 2024Break; Break
A PHYSICIAN REPORTED THAT DURING SURGERY, PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURE WHILE REMOVING CORTEX WITH THE IRRIGATION ASPIRATION HANDPIECE. IT WAS NOTED THAT THE SUCTION PORT OF THE IRRIGATION ASPIRATION TIP WAS DAMAGED, LIKELY DUE TO A BURR ON THE TIP. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE TIP AND BY CHANGING THE TYPE OF INTRAOCULAR LENS (IOL) FROM A SINGLE-PIECE IOL TO A THREE-PIECE IOL, WHICH WAS SCHEDULED FOR INSERTION.
Patient problems: Rupture
MAUDE report 20706617 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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