CONSTELLATION 8065753041Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION TABLE TOP · Class 2
Quick summary
This Alcon Constellation eye surgery system is used in procedures such as vitrectomy, and its 510 reports often describe the cutting blade failing to cut, power output problems, and weak suction. Some describe a light source failing before cataract surgery. There are no deaths and 35 injuries reported, some involving eye pressure dropping or endophthalmitis, an eye infection. No recalls name this device, and reports fell to 77 in the past year from 149 the year before.
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
- 503
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 503 adverse event reports that list this exact device (DI 00380657530410), received between Mar 26, 2021 and Sep 22, 2026 — classified as 35 injuries, 468 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (100 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
- Failure to Cut100
- Appropriate Device Problem Term/Code Not Available67
- Energy Output Problem38
- Failure to Deliver Energy33
- Suction Failure31
- Pressure Problem28
- Failure to Fire26
- Output Problem23
Patient problems
- No Clinical Signs, Symptoms or Conditions280
- Insufficient Information190
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Intraocular Pressure Decreased13
- Endophthalmitis9
- Blurred Vision6
- Conjunctivitis6
- Iritis6
Recent adverse event reports
The 25 most recent of 503 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Failure to Cut
A healthcare professional reported that the cutter was not functioning on the ophthalmic system before surgery. The surgery was completed on the same day using an alternative system.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851427 ↗MalfunctionSep 5, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50629153 ↗MalfunctionSep 4, 2026Pressure Problem
A customer reported that during surgery, an ophthalmic system had intraocular pressure problem. The surgery was completed on the same day with another cassette. The procedure type was not reported. No patient impact was reported. Additional information has been requested, but none received till date. This complaint pertains to ophthalmic system involved in the reported events.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50608101 ↗MalfunctionAug 27, 2026Failure to Cut
A customer reported that during vitrectomy surgery console vitrectomy blade was not moving. Procedure was completed on the same day without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50468323 ↗MalfunctionAug 26, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50454335 ↗MalfunctionAug 25, 2026Output Problem
A customer reported that, prior to cataract surgery with intraocular lens implantation, the primary light source of an ophthalmic system failed. The surgery was completed on the same day using a secondary illumination module, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431129 ↗MalfunctionAug 21, 2026Failure to Fire
Patient problems: Insufficient Information
MAUDE report 50373399 ↗MalfunctionAug 21, 2026Gas Output Problem
A customer reported that the gas in an ophthalmic system would not fill and there was no patient contact. Procedure details have not been provided. Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50371280 ↗MalfunctionAug 21, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50370974 ↗MalfunctionAug 7, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50176001 ↗MalfunctionAug 7, 2026Suction Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175536 ↗MalfunctionAug 7, 2026Suction Failure
Patient problems: Insufficient Information
MAUDE report 50170695 ↗MalfunctionAug 6, 2026Unexpected Shutdown
Patient problems: Insufficient Information
MAUDE report 50158482 ↗MalfunctionAug 6, 2026Failure to Fire
Patient problems: Insufficient Information
MAUDE report 50156851 ↗MalfunctionAug 4, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50127185 ↗MalfunctionJul 30, 2026Suction Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082950 ↗MalfunctionJul 29, 2026No Device Output
A physician reported that, during surgery ultrasound of an ophthalmic operating system did not oscillate. The surgery was completed on the same day using a replacement device. Procedure details and patient impact have not been reported.
Patient problems: Insufficient Information
MAUDE report 50066563 ↗MalfunctionJul 16, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 25838481 ↗MalfunctionJul 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25824281 ↗MalfunctionJun 17, 2026Failure to Cut; Suction Failure
A CUSTOMER REPORTED THAT THE OPHTHALMIC SYSTEM HAD AN ISSUE WITH THE VITRECTOMY FUNCTION, WHICH WAS NOT ASPIRATING OR CUTTING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25532729 ↗MalfunctionJun 12, 2026Output Problem
A CUSTOMER REPORTED THAT DURING A VITREORETINAL SURGERY, AN OPHTHALMIC SYSTEM EXHIBITED LOW ILLUMINATION ACROSS MULTIPLE PORTS. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER ILLUMINATION PROBE, WITH NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485479 ↗MalfunctionJun 12, 2026Failure to Cut
A PHYSICIAN REPORTED THAT AN OPHTHALMIC VITRECTOMY CUTTER PROBE WAS NOT WORKING BEFORE THE SURGERY. THE PROCEDURE TYPE WAS NOT REPORTED. THE SURGERY WAS COMPLETED WITH ANOTHER CUTTER. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484698 ↗MalfunctionMay 7, 2026Failure to Cut
A CUSTOMER REPORTED THAT THE OPHTHALMIC CONSOLE EXPERIENCED A PROBLEM WITH NONEXISTENT VITRECTOMY CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111278 ↗MalfunctionApr 30, 2026Failure to Cut
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC SYSTEM HAD NO CUTTING. THE SURGERY WAS COMPLETED WITH ALTERNATIVE SYSTEM WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25040590 ↗MalfunctionApr 28, 2026Output Problem
A CUSTOMER REPORTED THAT THE OPHTHALMIC SYSTEM LAMP IN THE UPPER ILLUMINATION MODULE WAS NOT FUNCTIONING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25013647 ↗
Other Instrument, vitreous aspiration and cutting, ac-powered devices
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- 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.