Centurion 8065753057Recalls & reported problems
Alcon Laboratories, Inc. · Centurion Vision System With Active Sentry · Class 2
Quick summary
This Alcon Centurion Vision System, an eye surgery system, appears in 632 adverse event reports, including 151 injuries and no deaths. Many reports describe suction failures, unexpected shutdowns, and energy delivery failures. 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
- 639
- Deaths reported
- 0
- Injuries reported
- 151
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 639 adverse event reports that list this exact device (DI 00380657530571), received between Apr 16, 2021 and Sep 29, 2026 — classified as 151 injuries, 488 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (86 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
- Adverse Event Without Identified Device or Use Problem94
- Suction Problem86
- Unexpected Shutdown76
- Failure to Deliver Energy58
- Suction Failure58
- Decrease in Suction53
- Inability to Irrigate52
- Energy Output Problem39
Patient problems
- No Clinical Signs, Symptoms or Conditions337
- Insufficient Information140
- Corneal Edema44
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available41
- Blurred Vision30
- Capsular Bag Tear30
- Eye Burn27
- Intraocular Pressure Decreased23
Recent adverse event reports
The 25 most recent of 639 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Improper Flow or Infusion; Audible Prompt/Feedback Problem
A nurse reported that during cataract surgery, the ophthalmic system displayed a system message code. While aspirating the viscoelastic following lens insertion, a strange sound was heard, and no fluid was flowing through the irrigators. The procedure was completed on the same day. Information regarding the patient has not been provided.
Patient problems: Insufficient Information
MAUDE report 50930044 ↗MalfunctionSep 25, 2026No Device Output
A customer reported that the operating handpiece on the ophthalmic console successfully completed prime and tune but did not deliver phacoemulsification energy when used in the eye. Procedure details were not provided. No patient impact was reported.This complaint is pertaining the system issue received from the initial reporter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895296 ↗MalfunctionSep 25, 2026Unexpected Shutdown
A customer reported that, an ophthalmic system shutdown on its own. Procedure details and patient impact have not been provided. Additional information has been requested, none received at this time of report.
Patient problems: Insufficient Information
MAUDE report 50895066 ↗MalfunctionSep 18, 2026No Device Output
A physician reported that during surgery, an ophthalmic system ultrasound output ceased during ultrasound. The surgery was completed after repriming. There was no further patient impact was reported.
Patient problems: Insufficient Information
MAUDE report 50814739 ↗MalfunctionSep 17, 2026Suction Problem
A customer reported that ophthalmic console exhibited issue with vacuum in quadrant mode of the surgery. The procedure details and patient impact was not reported.
Patient problems: Insufficient Information
MAUDE report 50800778 ↗MalfunctionSep 15, 2026No Device Output
A customer reported that an ophthalmic console did not perform phacoemulsification during the cataract surgery. The patient impact was reported as unknown. The surgery completion status was not reported. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50766982 ↗MalfunctionSep 7, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50648296 ↗MalfunctionSep 7, 2026Suction Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50646841 ↗MalfunctionSep 4, 2026No Device Output
A healthcare professional reported that during cataract surgery phacoemulsification power was lost during quad mode while using an ophthalmic system. The surgery was completed on the same day by using an alternative handpiece and there was no patient harm.This complaint is pertaining the one of two reports received from the initial reporter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615647 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
A customer reported that patient experienced a capsular bag rupture while using an ophthalmic operating system during cataract surgery. Additional information has been requested, none received till date.
Patient problems: Capsular Bag Tear
MAUDE report 50589625 ↗MalfunctionSep 3, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581735 ↗MalfunctionSep 3, 2026Failure to Cut
A physician reported that, during surgery cutter connected to an ophthalmic system did not function. The cutter was replaced to resolve the issue. Procedure details are unknown, and there was no patient impact. 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 50581734 ↗MalfunctionAug 18, 2026No Device Output
Patient problems: Insufficient Information
MAUDE report 50297242 ↗MalfunctionAug 18, 2026Pressure Problem
A customer reported that an ophthalmic console's exhibit unstable chamber. The details of the procedure and patient health impact have not been provided. Additional information has been requested and none received at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292451 ↗MalfunctionAug 18, 2026Pressure Problem
A customer reported that an ophthalmic console's exhibit unstable chamber. The details of the procedure and patient health impact have not been provided. Additional information has been requested and none received at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292450 ↗MalfunctionAug 14, 2026Suction Problem; Suction Failure
Patient problems: Insufficient Information
MAUDE report 50252727 ↗MalfunctionAug 12, 2026No Device Output; Suction Failure
Patient problems: Insufficient Information
MAUDE report 50218882 ↗MalfunctionAug 11, 2026Suction Problem
A customer reported that during cataract surgery, the ophthalmic system failed to provide adequate suction during quadrant removal, resulting in lens fragments not remaining engaged on the phacoemulsification tip. The customer further reported an absence of suction into the handpiece during cortex removal. 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 one of the two reports from the same facility.
Patient problems: Insufficient Information
MAUDE report 50207436 ↗InjuryAug 7, 2026Infusion or Flow Problem
A non healthcare professional reported that during the cataract surgery using an ophthalmic system, the vacuum/aspiration seemed normal but the irrigation abruptly turned off while removing the last nuclear quadrant, the anterior chamber collapsed and got a hole in my posterior capsule and resultant anterior vitrectomy, a single piece intraocular lens (IOL) was inserted. Procedure details were unknown. The current condition of patient was unknown.This report pertains to an ophthalmic system involved for this complaint.
Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased
MAUDE report 50177261 ↗InjuryAug 5, 2026Improper Flow or Infusion
A customer reported that during the cataract surgery with intraocular implantation, ophthalmic system exhibited irrigation stopped when removing the last nuclear quadrant and patient experienced anterior chamber collapsed and hole in posterior capsule. It is unknown whether the procedure was completed. Outcome of the patient was unknown.This report is pertaining to second of two patients from the same facility.
Patient problems: Intraocular Pressure Decreased; Retinal Tear
MAUDE report 50144656 ↗MalfunctionJul 31, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099637 ↗MalfunctionJul 31, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099635 ↗MalfunctionJul 31, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099633 ↗MalfunctionJul 31, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099456 ↗MalfunctionJul 31, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099436 ↗
Other Unit, phacofragmentation devices
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- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751613Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall222 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.