CONSTELLATION 8065751450Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION EMBEDDED LASER · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657514502), received between Feb 1, 2022 and Apr 2, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Energy Output Problem” (3 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
- Energy Output Problem3
- Failure to Deliver Energy3
- Appropriate Device Problem Term/Code Not Available1
- Noise, Audible1
- Pressure Problem1
- Self-Activation or Keying1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
- Choroidal Hemorrhage1
- Intraocular Pressure Decreased1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown
A REPORT RECEIVED VIA HEALTH AUTHORITY DURING THE VITRECTOMY SURGERY AN OPHTHALMIC SYSTEM DISPLAYED AN ERROR MESSAGE AND EXHIBITED OPERATIONAL FAILURE WITH UNEXPECTED SHUTDOWN. THERE WAS A SUDDEN FLASH OCCURRED AT THE CONNECTOR PART. THE DETAILS OF THE PATIENT IMPACT 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 24765108 ↗InjuryJan 30, 2026Pressure Problem
A GOVERNMENT AGENCY REPORTED THAT, DURING GAS-LIQUID EXCHANGE OF VITRECTOMY SURGERY, THERE WAS AN UNSTABLE INTRAOCULAR PRESSURE RESULTED IN DECREASED INTRAOCULAR PRESSURE AND BLEEDING WHILE USING AN OPHTHALMIC OPERATING SYSTEM. GAS LIQUID EXCHANGE WAS TEMPORARILY SUSPENDED, AND INTRAOCULAR PERFUSION ADJUSTMENT WAS PERFORMED.
Patient problems: Choroidal Hemorrhage; Intraocular Pressure Decreased
MAUDE report 24221970 ↗MalfunctionApr 25, 2025Energy Output Problem; Energy Output Problem
A NURSE REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM WITH THE LASER KEY NOT WORKING BEFORE SURGERY. SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909513 ↗MalfunctionJan 20, 2025Energy Output Problem; Energy Output Problem
THE GOVERNMENT AGENCY REPORTED THAT DURING CATARACT SURGERY OUTPUT ENERGY FROM AN OPHTHALMIC SYSTEM WAS TOO LOW WHILE REMOVING OF THE VITREOUS BODY FROM THE PATIENT LEFT EYE. THE PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21190129 ↗MalfunctionNov 28, 2024Self-Activation or Keying; Self-Activation or Keying
A PHYSICIAN REPORTED THAT DURING CATARACT VITRECTOMY COMBINATION SURGERY AN OPHTHALMIC OPERATING SYSTEM CHANGED THE STATUS FROM LASER READY TO LASER STANDBY ON ITS OWN MULTIPLE TIMES. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER SWITCHED IT BACK TO LASER READY. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805465 ↗MalfunctionApr 30, 2024Failure to Deliver Energy; Noise, Audible; Failure to Deliver Energy; Noise, Audible
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC CONSOLE LASER WERE CHANGED THE NOISE AND NOT FIRING. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213975 ↗MalfunctionNov 14, 2022Failure to Deliver Energy; Failure to Deliver Energy
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CONSOLE EXHIBITED FOOTSWITCH ISSUE WHICH CAUSED A PAUSE IN LASER TREATMENT. AT EACH PEDAL STROKE, THE LASER PAUSED, AND NO IMPACT WAS DELIVERED. THE MACHINE VOICE INDICATED LASER PAUSED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LASER POSTPONED TO FURTHER CONSULTATION. THERE WAS NO REPORT ON PATIENT HEALTH CURRENT CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787253 ↗MalfunctionOct 31, 2022Failure to Deliver Energy; Failure to Deliver Energy
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC CONSOLE LASER STOPPED WORKING. SURGERY WAS COMPLETED AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15697819 ↗MalfunctionFeb 1, 2022Energy Output Problem; Energy Output Problem
A NURSE REPORTED THAT AN OPHTHALMIC EMBEDDED LASER SYSTEM PRESENTED LOW LASER ENERGY DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13420002 ↗
Other SOURCE, ABORTION UNIT, VACUUM devices
- PUREPOINT 8065750597Alcon Laboratories, Inc. · SOURCE, ABORTION UNIT, VACUUM242 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.