Alcon, Infiniti, IntrepidRecalls & reported problems across all models
Alcon Laboratories, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Alcon, Infiniti, Intrepid model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 9 models of Alcon, Infiniti, Intrepid by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2021 and Jun 5, 2024 — classified as 2 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (18 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Alcon, Infiniti, Intrepid recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 28, 2023Open, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2408-2023 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported Alcon, Infiniti, Intrepid problems
Device problems
- Suction Failure18
- Inability to Irrigate8
- Noise, Audible7
- Complete Blockage3
- Suction Problem3
- Detachment of Device or Device Component2
- No Flow2
- Particulates2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
- Unspecified Eye / Vision Problem1
- Zonular Dehiscence1
Alcon, Infiniti, Intrepid models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Infiniti, Intrepid 8065752087Unit, phacofragmentation1 recall4 reports
- Alcon, Infiniti, Intrepid 8065752086Unit, phacofragmentation1 recall1 report
- Alcon, Infiniti, Intrepid 8065752093Unit, phacofragmentation1 recall1 report
- Alcon, Infiniti, Intrepid 8065752090Instrument, vitreous aspiration and cutting, ac-powered1 recall0 reports
- Alcon, Infiniti, Intrepid 8065752094Unit, phacofragmentation1 recall0 reports
- Alcon, Infiniti, Intrepid 8065752095Unit, phacofragmentation1 recall0 reports
- Alcon, Infiniti, Intrepid 8065752096Unit, phacofragmentation1 recall0 reports
- Alcon, Infiniti, Intrepid 8065752088Unit, phacofragmentation26 reports
- Alcon, Infiniti, Intrepid 8065752082Unit, phacofragmentation12 reports
Recent Alcon, Infiniti, Intrepid adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Noise, Audible; Noise, Audible
A PHYSICIAN REPORTED THAT AN ABNORMAL SOUND HEARD WHEN USING THE PRODUCT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19469624 ↗MalfunctionMay 7, 2024Noise, Audible; Noise, Audible
A PHYSICIAN REPORTED THAT ABNORMAL NOISE WAS HEARD FROM AROUND THE DRAIN BAG JOINT OF THE PACK DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM AND PROCEDURE TYPE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19256879 ↗MalfunctionApr 18, 2024Ambient Noise Problem; Ambient Noise Problem
A PHYSICIAN REPORTED THAT THE STRANGE SOUND WAS HEARD DURING SURGERY. THE PROCEDURE DETAILS WERE UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19131706 ↗MalfunctionApr 16, 2024Complete Blockage; Complete Blockage
THE PHYSICIAN REPORTED THAT ABNORMAL NOISE WAS HEARD FROM THE PAK DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PRODUCT. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114141 ↗MalfunctionJan 11, 2024Noise, Audible; Noise, Audible
A PHARMACIST REPORTED THAT CASSETTE STARTED TO FAIL BY EMITTING A SOUND THAT HAD NEVER BEEN PRESENTED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS OTHER. THERE WAS NO INFORMATION ABOUT PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 18492096 ↗MalfunctionDec 4, 2023Inability to Irrigate; Inability to Irrigate
A PHYSICIAN REPORTED THAT NO IRRIGATION IN THE DRAIN BAG AND LEAK FROM AROUND THE DRAIN BAG DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18264076 ↗MalfunctionNov 1, 2023Suction Failure; Suction Failure
A PHARMACIST REPORTED THAT WATER LEAK WAS OBSERVED AND THE VACUUM WAS NOT GOOD DURING THE CATARACT [WITH INTRAOCULAR (IOL) IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER THE REPLACING THE CASSETTE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049106 ↗MalfunctionAug 21, 2023Noise, Audible; Noise, Audible
A PHYSICIAN REPORTED THAT AN UNFAMILIAR SOUND WAS HEARD FROM THE AREA AROUND THE CASSETTE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17584173 ↗MalfunctionJul 25, 2023Noise, Audible; Suction Failure; Noise, Audible; Suction Failure
A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED, AND ABNORMAL NOISE WAS HEARD FROM THE ROLLER AREA DURING CATARACT SURGERY. IRRIGATING SOLUTION DIDN'T SEEM TO BE KEEPING UP, AND THE ANTERIOR CHAMBER BECAME UNSTABLE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN CONFIRMING THAT THE PAK WAS REPLACED AND THE SAME ISSUE WAS RECURRED, HOWEVER THE SURGERY WAS PERFORMED AND COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389915 ↗MalfunctionJul 25, 2023Noise, Audible; Suction Failure; Noise, Audible; Suction Failure
A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED, AND ABNORMAL NOISE WAS HEARD FROM THE ROLLER AREA DURING CATARACT SURGERY. IRRIGATING SOLUTION DIDN'T SEEM TO BE KEEPING UP, AND THE ANTERIOR CHAMBER BECAME UNSTABLE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN CONFIRMING THAT THE PAK WAS REPLACED AND THE SAME ISSUE WAS RECURRED, HOWEVER THE SURGERY WAS PERFORMED AND COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389630 ↗MalfunctionJul 17, 2023Complete Blockage; Suction Failure; Complete Blockage; Suction Failure
A PHYSICIAN REPORTED THAT AN ABNORMAL SOUND WAS HEARD, AND ASPIRATION FAILURE OCCURRED DURING THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17332420 ↗MalfunctionJun 20, 2023Noise, Audible; Noise, Audible
A CUSTOMER REPORTED THAT THE PAK MADE A LOUD NOISE AND BACK OF THE CASSETTE WAS PROTRUDING AND BUBBLE OUTWARD DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162241 ↗MalfunctionApr 28, 2023Partial Blockage; Partial Blockage
A CUSTOMER REPORTED THAT THE CASSETTE WAS LEAKING AND PARTIALLY CLOGGED DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16833851 ↗MalfunctionApr 12, 2023Suction Failure; Suction Failure
A PHYSICIAN REPORTED ADVISORY CODE WAS DISPLAYED AND NO ASPIRATION WAS APPLIED AT ALL DURING THE PHACOEMULSIFICATION MODE OF SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PAK WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16729083 ↗MalfunctionMar 21, 2023Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION COULD NOT BE PERFORMED DURING ULTRASOUND SURGERY WITH NO HARM TO PATIENT, SITUATION DID NOT IMPROVE EVEN AFTER THE PRODUCT WAS REPLACED FOR TIP AND HANDPIECE, HOWEVER IT ONLY IMPROVED WHEN THE CASSETTE WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16583010 ↗
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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