InfinitiRecalls & reported problems across all models
Alcon Laboratories, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of Infiniti by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and Oct 23, 2025 — classified as 4 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (25 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 Infiniti problems
Device problems
- Unexpected Shutdown25
- Operating System Becomes Nonfunctional16
- Failure to Cut11
- Failure to Deliver Energy6
- Appropriate Device Problem Term/Code Not Available3
- Decrease in Suction3
- Overheating of Device3
- Suction Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema2
- Hemorrhage/Blood Loss/Bleeding1
Infiniti models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infiniti 8065752160Instrument, vitreous aspiration and cutting, ac-powered54 reports
- Infiniti 8065750157Unit, phacofragmentation10 reports
- Infiniti 8065750121Unit, phacofragmentation8 reports
Recent Infiniti adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER WAS NOT CUTTING BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW SURGERY GOT COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23370015 ↗MalfunctionFeb 26, 2025Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY OPHTHALMIC SYSTEM SHUT DOWN ON ITS OWN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY RESTARTING THE SYSTEM AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21466309 ↗MalfunctionJul 15, 2024Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT ULTRA IRRIGATION HOSES HAD BROKEN DURING CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANT. SURGERY COMPLETION WAS UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19744310 ↗MalfunctionNov 28, 2023Failure to Prime; Suction Failure; Failure to Prime; Suction Failure
A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE SUCTION WAS NOT WORKING DURING A CATARACT SURGERY DURING PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED BY AN ALTERNATE HANDPIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18215169 ↗MalfunctionNov 10, 2023Partial Blockage; Decrease in Suction; Partial Blockage; Decrease in Suction
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC HANDPIECE PRESENTED WITH OCCLUSION AND LOW ASPIRATION IN SCULPT MODE. PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18110438 ↗MalfunctionOct 19, 2023Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM AUTOMATICALLY RESTARTS ON ITS OWN AFTER THE BOOTUP SEQUENCE. THE SURGERY WAS COMPLETED AFTER THE REBOOTING. THERE WAS O PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17962907 ↗MalfunctionOct 13, 2023Failure to Cut; Failure to Cut
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CONSOLE FAILED O PERFORM CUTTING. SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929406 ↗MalfunctionSep 29, 2023Overheating of Device; Overheating of Device
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY THE PHACOEMULSIFICATION HANDPIECE GOT HOT. THE SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17842178 ↗MalfunctionAug 8, 2023Inability to Irrigate; Inability to Irrigate
A NURSE REPORTED THAT AN OPHTHALMIC SYSTEM EXHIBITED WITH FAILED FLUIDICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480498 ↗InjuryMay 8, 2023Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY AN OPHTHALMIC HANDPIECE WOULD NOT DELIVER THE PHACOEMULSIFICATION POWER AND THE HANDPIECE CONNECTOR WAS DAMAGED WITH BURN SPOTS AT THE CONNECTOR TIP. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING TO THE ALTERNATIVE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16885321 ↗MalfunctionApr 28, 2023Overheating of Device; Overheating of Device
A PHYSICIAN REPORTED THAT OPHTHALMIC HANDPIECE HAS THREE HOT SPOTS AT THE SAME LATITUDE ON THE TAIL WERE FOUND. THE HANDPIECE HEAT WAS INCREASES FROM THE INSIDE OUT, AND THEN THE TEMPERATURE IS CONCENTRATED IN THREE POSITIONS OF THE HANDPIECE, RESULTING IN HOT SPOTS NO REPORT OF ANY PATIENT HARM. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16831563 ↗MalfunctionApr 3, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CONSOLE HAS STOPPED WORKING AT THE MIDDLE OF THE SURGERY. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662226 ↗MalfunctionFeb 22, 2023Unexpected Shutdown; Unexpected Shutdown
A NURSE REPORTED THAT AN OPHTHALMIC CONSOLE HAS STOPPED WORKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16415331 ↗MalfunctionJan 25, 2023Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CONSOLE HAD ABNORMAL SHUTDOWN DURING CATARACT SURGERY, NO ERROR CODE DISPLAYED. THE PROCEDURE WAS COMPLETED BY RESTARTING THE CONSOLE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240076 ↗MalfunctionJan 13, 2023Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED OPHTHALMIC CONSOLE SWITCHED OFF ON ITS OWN DURING PHACOEMULSIFICATION AND DISPLAYED ERROR 472 WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16160369 ↗
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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