CONSTELLATION 8065751150Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION TABLE TOP · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon Constellation eye surgery console has 1,248 adverse event reports, with no deaths and 64 injuries. The reports describe the cutter stopping or losing suction during vitrectomy surgery, energy output problems, and unexpected shutdowns. There is 1 open recall, started in August 2023, about a circuit board change that could cause component failure and loss of pressure control for the cutters. Reports in the last 12 months (70) are fewer than in the 12 months before (122).
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
- 1,246
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,246 adverse event reports that list this exact device (DI 00380657511501), received between Mar 3, 2021 and Sep 28, 2026 — classified as 63 injuries, 1,183 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (191 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Aug 18, 2023Open, Classified
Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
Z-0099-2024 · Root cause: Component change control · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available264
- Failure to Cut191
- Energy Output Problem179
- Unexpected Shutdown77
- Failure to Deliver Energy74
- Suction Problem69
- Operating System Becomes Nonfunctional64
- Decrease in Suction62
Patient problems
- No Clinical Signs, Symptoms or Conditions908
- Insufficient Information252
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available46
- Intraocular Pressure Decreased23
- Endophthalmitis10
- Eye Burn9
- Capsular Bag Tear8
- Intraocular Pressure Increased7
Recent adverse event reports
The 25 most recent of 1,246 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Cut
A nurse reported that during surgery, an ophthalmic system cutter did not work. Procedure details are unknown. It is also unclear whether the surgery was completed. There was no further patient impact was reported. Additional information has been requested but is not available at the time of this report.This complaint pertains to ophthalmic system involved in the reported events.
Patient problems: Insufficient Information
MAUDE report 50912336 ↗MalfunctionSep 25, 2026Energy Output Problem
A customer reported of laser issue in an ophthalmic system. Procedure details and patient impact have not been provided.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50897579 ↗MalfunctionSep 16, 2026Failure to Fire
A customer reported that system represented with laser problems. Procedure details and patient details were not reported. Additional information has been requested none received till date.
Patient problems: Insufficient Information
MAUDE report 50784974 ↗MalfunctionSep 3, 2026Infusion or Flow Problem
A customer reported that an ophthalmic system had Viscous Fluid Control Failure (VFC). 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 50589078 ↗MalfunctionAug 26, 2026Failure to Cut
The customer reported that an ophthalmic system cutter stopped working during middle of the case. Details of procedure and patient impact was not reported. It is also unclear whether the surgery was completed. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50446409 ↗MalfunctionAug 25, 2026Failure to Power Up; Failure to Cut; Computer Operating System Problem; Suction Failure
A physician reported that, during a vitrectomy surgery, an ophthalmic console took significantly longer than expected to start up, and there was an unexpected change in the saved surgical settings. In addition, while using the foot pedal for vitrectomy, the cutter rate progressively decreased without user intervention, and the aspiration level gradually diminished until no aspiration was present. The procedure was completed on the same day. No adverse patient outcome was reported.Additional information has been requested; however, none has been received to date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50426303 ↗MalfunctionAug 14, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50252255 ↗MalfunctionAug 13, 2026Pressure Problem
Patient problems: Intraocular Pressure Decreased
MAUDE report 50233979 ↗MalfunctionAug 13, 2026Failure to Cut; Suction Failure
A Physician reported that during a vitrectomy procedure, the ophthalmic cutter on the operating console stopped working and vacuum power was lost. The vitrectomy cutter and cassette were replaced and repriming the system was completed however, the issue continued to occur. The procedure was completed on the same day. The details of the patient impact have not been provided.
Patient problems: Insufficient Information
MAUDE report 50233805 ↗MalfunctionAug 12, 2026Pressure Problem
A customer reported that an ophthalmic console exhibited an unstable intraocular pressure and patient experienced hypotony during the aspiration phase of vitrectomy surgery. The current outcome of the patient condition was unknown. Additional information has been received and none received at the time of this report.
Patient problems: Intraocular Pressure Decreased
MAUDE report 50219193 ↗MalfunctionJul 29, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067348 ↗MalfunctionJul 29, 2026Failure to Fire
A customer reported that an ophthalmic operating system had low laser power. The details of the event and procedure was not reported. No patient impact was not reported. Additional information has been requested, but none received till date.
Patient problems: Insufficient Information
MAUDE report 50065975 ↗MalfunctionJul 15, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825445 ↗MalfunctionJul 14, 2026Energy Output Problem
Patient problems: Insufficient Information
MAUDE report 25810948 ↗MalfunctionJul 9, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 25761532 ↗MalfunctionJun 26, 2026Output Problem
A CUSTOMER REPORTED A FAILURE OF THE LAMP IN THE UPPER LIGHT UNIT OF AN OPHTHALMIC SYSTEM. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25632631 ↗MalfunctionJun 24, 2026Failure to Cut; Failure to Fire; Output below Specifications
A CUSTOMER REPORTED THAT OPHTHALMIC SYSTEM EXHIBITED WEAK AIMING BEAM, INTERMITTENT FIRING ON PORT TWO, VITRECTOMY CUTTERS NOT WORKING. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25610515 ↗MalfunctionJun 22, 2026Energy Output Problem
A CUSTOMER REPORTED THAT IN AN OPHTHALMIC SYSTEM LASER WAS TURNING OFF. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25577960 ↗MalfunctionJun 19, 2026Failure to Cut; Suction Failure
A CUSTOMER REPORTED VIA GOVERNMENT AGENCY THAT DURING VITRECTOMY PROCEDURE THE OPHTHALMIC REGULATOR WAS NOT READING THE GAS PRESSURE CORRECTLY, AND ANOTHER REGULATOR WAS SWAPPED, AFTER WHICH THE GAS READING WAS WITHIN RANGE. THE OPHTHALMIC VITRECTOR ON THE OPERATING CONSOLE WAS NOT WORKING PROPERLY (NEITHER CUTTING NOR VACUUMING). NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT PERTAINS TO OPHTHALMIC CONSOLE INVOLVED IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563920 ↗MalfunctionMay 13, 2026Pressure Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM HAD UNSTABLE INTRA OCULAR PRESSURE DURING VITRECTOMY SURGERY. DETAILS RELATED TO PATIENT HARM HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Insufficient Information
MAUDE report 25160658 ↗MalfunctionApr 30, 2026Energy Output Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM EXHIBITED LASER WAS DEFECTIVE. THE DETAILS OF THE EVENT AND PROCEDURE WAS NOT REPORTED. NO PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 25040764 ↗MalfunctionApr 16, 2026Output Problem
A CUSTOMER REPORTED THAT OPHTHALMIC ILLUMINATOR WAS NOT WORKING. EVENT DETAILS AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24893849 ↗MalfunctionApr 15, 2026Accessory Incompatible; Suction Problem; Failure to Cut; Suction Failure
A CUSTOMER REPORTED THAT DURING SURGERY, PROBLEMS WITH VITREOUS ASPIRATION IN AN OPHTHALMIC SYSTEM. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24883447 ↗MalfunctionApr 15, 2026Output Problem
A CUSTOMER REPORTED THAT THE OPHTHALMIC SYSTEM BULB IN THE OVERHEAD ILLUMINATOR WAS NOT WORKING. INFORMATION REGARDING THE PROCEDURE AND ANY POTENTIAL PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24882330 ↗MalfunctionApr 6, 2026Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE WAS NOT CUTTING WHEN USED WITH THE OPHTHALMIC SYSTEM. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24790662 ↗
Other Instrument, vitreous aspiration and cutting, ac-powered devices
- CONSTELLATION 8065753041Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered503 reports
- Centurion, OZil 8065751761Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered475 reports
- UNITY 00380650002969Alcon Laboratories, Inc. · Instrument, Vitreous Aspiration And Cutting, Ac-Powered271 reports
- Ozil 8065750469Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered261 reports
- Infiniti 8065752160Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered54 reports
- Bausch + Lomb SE5523WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall4 reports
- Bausch + Lomb SE5525WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall2 reports
- Bausch + Lomb SE5423WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.