Alcon 00380650001283Recalls & reported problems
Alcon Laboratories, Inc. · ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM Tipless · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650001283), received between Aug 22, 2022 and Sep 16, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (4 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.
Reports received per month
Most reported problems
Device problems
- Suction Failure4
- Complete Blockage1
- No Flow1
- Noise, Audible1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT FLUIDICS MANAGEMENT SYSTEM (FMS) PACK FAILED TO SUCTION DURING PHACO MODE OF CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224871 ↗MalfunctionJul 3, 2024No Flow; Suction Failure; No Flow; Suction Failure
A CUSTOMER REPORTED THAT NO VACUUM AND NO FLOW DURING SURGERY. THERE WAS NO PATIENT HARM REPORTED. THE PROCEDURE DETAILS WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19663231 ↗MalfunctionAug 21, 2023Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT THERE WAS NO VACUUM WITH USE OF THE CASSETTE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17585734 ↗MalfunctionMar 10, 2023Sharp Edges; Sharp Edges
A CUSTOMER REPORTED BARB WAS PRESENT AT THE TIP BEFORE A SURGERY. THERE WAS PATIENT CONTACT AND THE PRODUCT AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED THAT THERE WAS NO INDICATION OF PATIENT IMPACT AND NO ADDITIONAL FOLLOW-UP WILL BE CONDUCTED, DUE TO THE AGE OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522143 ↗MalfunctionAug 22, 2022Complete Blockage; Noise, Audible; Suction Failure; Complete Blockage; Noise, Audible; Suction Failure
A CUSTOMER REPORTED TUBING CLOGGING AND SYSTEM OCCLUSION TONE WAS HEARD DURING IRRIGATION/ASPIRATION PHASE OF A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15264847 ↗
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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