Infiniti 8065752160Recalls & reported problems
Alcon Laboratories, Inc. · Infiniti Vision System · Class 2
Quick summary
This Alcon Infiniti Vision System is a console used for cataract surgery. Most of the 54 reports describe the system shutting down or rebooting on its own, or its software freezing, sometimes mid-surgery — in the cases described, staff restarted the system or finished the procedure another way, with no patient harm noted. There are no deaths, one report involving an injury, and 53 malfunction reports. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00380657521609), received between Mar 3, 2021 and Feb 26, 2025 — classified as 1 injury, 53 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Shutdown25
- Operating System Becomes Nonfunctional16
- Failure to Cut3
- Failure to Deliver Energy3
- Application Program Freezes or Fails to Launch2
- Appropriate Device Problem Term/Code Not Available2
- Decrease in Suction2
- Suction Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 ↗MalfunctionJan 12, 2023Operating System Becomes Nonfunctional; Appropriate Device Problem Term/Code Not Available; Operating System Becomes Nonfunctional; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE WAS FREEZED AND CABLE ON FOOT PEDAL GOT FRAYED PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16145456 ↗MalfunctionOct 31, 2022Suction Problem; Suction Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CONSOLE EXHIBITED ASPIRATION ISSUE AND THE PHACOEMULSIFICATION TIP WAS OCCLUDED DURING PHACOEMULSIFICATION MODE (PHACO) OF A CATARACT PROCEDURE. THE SURGERY WAS COMPLETED BY CHANGING THE TIP. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15699951 ↗MalfunctionOct 31, 2022No Display/Image; Operating System Becomes Nonfunctional; No Display/Image; Operating System Becomes Nonfunctional
A PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE WAS LOCKED WITH A DARK SCREEN. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15699328 ↗MalfunctionOct 30, 2022Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE PRESENTED PROBLEMS OF INTERMITTENT SHUTDOWN BEFORE A CATARACT SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY BY RESTARTING THE CONSOLE. THERE WAS NO REPORT OF ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15697460 ↗MalfunctionOct 24, 2022Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THAT THE OPHTHALMIC CONSOLE SHUTS DOWN INTERMITTENTLY BEFORE SURGERY. THERE WAS NO ERROR CODE DISPLAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE SAME DAY. THE DETAILS ABOUT PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15658879 ↗MalfunctionOct 11, 2022Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE EXHIBITED SUDDEN SHUTDOWN WITHOUT DISPLAYING ANY SYSTEM MESSAGES AFTER A CATARACT SURGERY, THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579326 ↗MalfunctionOct 10, 2022Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC SURGICAL CONSOLE SHUT DOWN ON ITS OWN. THE CONSOLE HAD COMPLETED BOOT UP AND THE INCIDENT OCCURRED DURING THE END OF THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15569103 ↗MalfunctionOct 1, 2022Unexpected Shutdown; Unexpected Shutdown
ADDITIONAL CLARIFICATION WAS RECEIVED FROM THE CUSTOMER AND CONFIRMED THAT THE SYSTEM HUNG UP DURING STARTUP CONSIDERED AS BOOT-UP ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15525939 ↗MalfunctionSep 24, 2022Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SYSTEM DID NOT CUT DURING SURGERY. SURGERY COMPLETED WITHOUT ANY ISSUES BY FORCEPS. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481498 ↗MalfunctionSep 6, 2022Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC SURGICAL CONSOLE WAS SHUT DOWN ON ITS OWN. THERE WAS NO PATIENT IMPACT AND SURGERY COMPLETED BY RESTARTING THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15366957 ↗MalfunctionAug 26, 2022Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CONSOLE SHUT DOWN BY ITS OWN BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH ANOTHER CONSOLE. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15300210 ↗MalfunctionAug 19, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED THAT AN OPHTHALMIC CONSOLE FROZE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED AND INDICATED THAT THE PLANNED PROCEDURE WAS CATARACT AND THE PROCEDURE WAS COMPLETED USING A BACKUP SYSTEM. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258484 ↗MalfunctionAug 16, 2022Decrease in Suction; Decrease in Suction
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC SURGICAL CONSOLE DID NOT GET SUFFICIENT VACUUM IN PHACOEMULSIFICATION MODE. THE ISSUE OCCURRED DUE TO THE SETTINGS IN THE CONSOLE BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15231617 ↗MalfunctionAug 13, 2022Unexpected Shutdown; Unexpected Shutdown
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CONSOLE SWITCHING OFF ON ITS OWN. TIMING OF THE PROCEDURE AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PROCEDURE WAS COMPLETED BY RESTARTING THE CONSOLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15222533 ↗MalfunctionAug 12, 2022Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
A PHYSICIAN REPORTED THAT DURING A CATARACT AN OPHTHALMIC CONSOLE FROZE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15215752 ↗MalfunctionAug 11, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC SURGICAL CONSOLE HANG UP. THE SURGERY WAS COMPLETED SUCCESSFULLY BY RESTARTING THE CONSOLE. THERE WAS NO REPORT OF ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15215161 ↗MalfunctionJul 20, 2022Decrease in Suction; Failure to Deliver Energy; Decrease in Suction; Failure to Deliver Energy
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC OPERATING CONSOLE DID NOT ASPIRATE THE CATARACT AND NO ULTRASOUNDS WERE HEARD. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE CONSOLE COULD ASPIRATE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15065188 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.