Constellation 8065750888Recalls & reported problems
Alcon Laboratories, Inc. · Constellation Handpiece · Class 2
All models of Constellation (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657508884), received between Jun 9, 2022 and Sep 26, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Overheating of Device2
- Energy Output Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2023Energy Output Problem; Energy Output Problem
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY PHACOEMULSIFICATION HANDPIECE FAILED TO BREAK CATARACT EFFICIENTLY AND PATIENT'S NUCLEUS DROPPED POSTERIORLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS IS THREE OF FOUR REPORTS FOR THIS ISSUE AND REPRESENTS THE PHACOEMULSIFICATION HANDPIECE.
Patient problems: Capsular Bag Tear
MAUDE report 17815846 ↗InjuryJul 15, 2022Overheating of Device; Overheating of Device
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN PHACOEMULSIFICATION HANDPIECE TIP WAS HOT AND A THERMAL INJURY OCCURRED TO THE PATIENT IN THE CONJUNCTIVA AND SCLERA PERISCLEROTOMY (COAGULATION). THE SUTURES ALONG WITH USUAL POSTOPERATIVE TREATMENT WERE USED TO SEAL THE WOUND.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury
MAUDE report 15025654 ↗MalfunctionJun 9, 2022Overheating of Device; Overheating of Device
A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE AN OPHTHALMIC PHACOEMULSIFICATION HANDPIECE TIP WAS GETTING HEATED . PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14641512 ↗
Other Unit, phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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