Alcon 00380650001399Recalls & reported problems
Alcon Laboratories, Inc. · ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650001399), received between Jan 3, 2023 and Oct 10, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Accessory Incompatible” (1 report).
1 FDA recall record name this device's identifier, 1 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, 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
Recalls naming this device
- Jun 28, 2023Open, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2407-2023 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Accessory Incompatible1
- Fitting Problem1
- Material Twisted/Bent1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2023Accessory Incompatible; Accessory Incompatible
A CUSTOMER REPORTED THAT THE SLEEVES THAT WE HAD AND USED ON AN INFINITI MACHINE WERE ¿THICKER AND LESS PLIABLE¿ DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). 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 17903435 ↗MalfunctionAug 3, 2023Fitting Problem; Fitting Problem
A CUSTOMER REPORTED THAT THE SLEEVES ARE THINNER THAN USUAL, THE SLEEVES DO NOT FIT AS TIGHT ON THE TIPS AND THAT IS WHERE THE ¿EXTRA¿ FLUID WAS CAME FROM DURING CATARACT SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17450730 ↗MalfunctionJan 3, 2023Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure
A CUSTOMER REPORTED THEY HAD VACUUM ISSUES WHILE IN QUADRANT REMOVAL USING THE CASSETTE. IT WAS LATER REALIZED THAT THE FMS (FLUIDICS MANAGEMENT SYSTEM) WAS KINKED DUE TO WHICH THE ISSUE OCCURRED. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16086670 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.