Alcon, IntrepidRecalls & reported problems across all models
Alcon Laboratories, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 165
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls
- 0
We found 7 models of Alcon, Intrepid by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 165 adverse event reports in the FDA's MAUDE database, received between May 26, 2021 and Jul 3, 2026 — classified as 43 injuries, 122 malfunctions.
The most frequently reported specific device problem is “Break” (34 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 Alcon, Intrepid problems
Device problems
- Break34
- Suction Failure30
- Material Twisted/Bent26
- Adverse Event Without Identified Device or Use Problem23
- Sharp Edges20
- Complete Blockage15
- Obstruction of Flow7
- Decrease in Suction5
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- Insufficient Information40
- Capsular Bag Tear26
- Toxic Anterior Segment Syndrome (TASS)13
- Uveitis10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Corneal Edema5
- Vitritis4
Alcon, Intrepid models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Intrepid 8065751511Unit, phacofragmentation45 reports
- Alcon, Intrepid 8065751512Unit, phacofragmentation31 reports
- Alcon, Intrepid 8065751510Unit, phacofragmentation29 reports
- Alcon, Intrepid 8065751922Unit, phacofragmentation20 reports
- Alcon, Intrepid 8065752145Unit, phacofragmentation19 reports
- Alcon, Intrepid 8065752144Unit, phacofragmentation11 reports
- Alcon, Intrepid 8065752146Unit, phacofragmentation10 reports
Recent Alcon, Intrepid adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 19, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT BEFORE A SURGERY AN OPHTHALMIC TIP WAS FOUND TO BE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25561905 ↗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 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 ↗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 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE LEFT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO SEVEN OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632158 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO FIVE OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631311 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO SIX OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629256 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO THREE OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629247 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO FOUR OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629116 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO TWO OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625543 ↗MalfunctionMar 18, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO ONE OF SEVEN REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625491 ↗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 27, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT BEFORE SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND BENT. PROCEDURE DETAILS AND PATIENT IMPACT 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 24468301 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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