ConstellationRecalls & reported problems across all models
Alcon Laboratories, Inc. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Constellation model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,176
- Deaths reported
- 0
- Injuries reported
- 124
- Recalls
- 4
We found 13 models of Constellation by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 2,176 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and Sep 28, 2026 — classified as 124 injuries, 2,052 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (294 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Constellation recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 5, 2025Class IIOpen, Classified
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0305-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Apr 28, 2025Class IIOpen, Classified
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Z-2109-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 18, 2023Class IIOpen, 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 · Recall details · FDA record ↗
- Jun 28, 2023Class IIOpen, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2406-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Constellation problems
Device problems
- Appropriate Device Problem Term/Code Not Available335
- Failure to Cut294
- Energy Output Problem221
- Suction Failure142
- Suction Problem115
- Failure to Deliver Energy110
- Unexpected Shutdown101
- Pressure Problem88
Patient problems
- No Clinical Signs, Symptoms or Conditions1,531
- Insufficient Information507
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available71
- Intraocular Pressure Decreased40
- Endophthalmitis21
- Eye Burn14
- Capsular Bag Tear12
- Intraocular Pressure Increased9
Constellation models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONSTELLATION 8065751150Instrument, vitreous aspiration and cutting, ac-powered1 recall1,246 reports
- CONSTELLATION 8065753041Instrument, vitreous aspiration and cutting, ac-powered503 reports
- Constellation 8065751155Unit, phacofragmentation1 recall220 reports
- Constellation 8065750957Unit, phacofragmentation1 recall138 reports
- Constellation 8065750918Unit, phacofragmentation1 recall12 reports
- Constellation 8065750958Unit, phacofragmentation1 recall8 reports
- Constellation 8065750914Unit, phacofragmentation32 reports
- CONSTELLATION 8065751450SOURCE, ABORTION UNIT, VACUUM9 reports
- Constellation 8065750888Unit, phacofragmentation3 reports
- CONSTELLATION 8065750977Instrument, vitreous aspiration and cutting, ac-powered2 reports
- Constellation 8065751158Unit, phacofragmentation1 report
- Constellation 8065751514Instrument, vitreous aspiration and cutting, ac-powered1 report
- Constellation 8065752151Instrument, vitreous aspiration and cutting, ac-powered1 report
Recent Constellation adverse event reports
The 15 most recent reports across all models, 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 24, 2026Use of Device Problem
A physician reported that negative pressure could not be generated during vitrectomy surgery. The surgery was completed on same day by replacing it with new product. There was no information reported about patient impact.
Patient problems: Insufficient Information
MAUDE report 50883323 ↗MalfunctionSep 23, 2026Suction Problem
A physician reported that ultrasound could not be used due to high aspiration resistance during the surgery. The procedure type was unknown. The surgery was completed on the same day after replacing the product with another one. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870520 ↗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 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 13, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747684 ↗MalfunctionSep 11, 2026Use of Device Problem
A Nurse reported that plunger of the viscoelastic control set failed at a vacuum setting during surgery. The Procedure type was unknown. The surgery was successfully completed after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731936 ↗MalfunctionSep 9, 2026Use of Device Problem
A nurse reported that under a vacuum pressure of 650 millimeters of mercury, plunger failed to retract properly, preventing normal silicone oil removal during surgery. The procedure type was unknown. The surgery was successfully completed on same day by replacing it with new viscoelastic control tubing. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693362 ↗MalfunctionSep 9, 2026Defective Alarm
A physician reported that the unable to create vacuum during vitrectomy surgery. The surgery was completed on the same day after replacing the new tube. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50686483 ↗MalfunctionSep 8, 2026Use of Device Problem
A nurse reported that the surgeon performed a left eye silicone oil removal surgery. After completing the patient's preliminary surgical preparations, the surgeon prepared to remove the silicone oil. The viscoelastic control tubing was opened, and the plunger within the tubing was fully advanced into the syringe before being connected to the machine for silicone oil removal. During the procedure, it was observed that under a vacuum setting of 650 millimeters of mercury (mmHg), the plunger failed to retract normally, preventing the silicone oil removal procedure from being carried out as intended. The surgery was completed on same day after replacing the product with another one, and there were no other abnormalities. The patient returned smoothly to the ward after completing the surgery. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672150 ↗MalfunctionSep 8, 2026Use of Device Problem
A nurse reported that the surgeon performed a right eye silicone oil removal procedure. After completion of the initial surgical steps, preparation was made for silicone oil extraction. The viscoelastic control tubing was opened, and the plunger within the tubing was inserted into the syringe and connected to the machine. During silicone oil removal, it was observed that the plunger could not retract under a vacuum setting of 650 millimeters of mercury (mmHg), preventing normal silicone oil extraction. A new viscoelastic control tubing set was replaced, and the procedure continued without further abnormalities. The patient completed the surgery and returned to the ward in stable condition. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671490 ↗MalfunctionSep 8, 2026Use of Device Problem
A non-healthcare professional reported that when surgeon about to inject silicone oil in eye, the injection cannula could not put in the trocar during vitrectomy surgery. After inspecting it was found the bending of cannula. The surgery was completed on the same day after replacing the cannula with new one. There was no patient contact with the suspect product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670838 ↗MalfunctionSep 8, 2026Leak/Splash
A physician reported that air had leaked at the interface of the tubing during vitrectomy surgery. The surgery was completed on same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50663053 ↗MalfunctionSep 8, 2026Use of Device Problem
A nurse reported that under a vacuum pressure of six hundred fifty millimeters of mercury, the plunger could not retract properly, preventing normal silicone oil removal during right eye silicone oil removal procedure. The surgery was completed on the same day after replacing the product with a new one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661788 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
- ClearCut17 models · 531 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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