Alcon 8065752183Recalls & reported problems
Alcon Laboratories, Inc. · ACTIVE FMS W/ INTREPID NANO 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 00380657521838), received between Apr 6, 2023 and Mar 21, 2025 — 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
- Ambient Noise Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Ambient Noise Problem; Ambient Noise Problem
A PHYSICIAN REPORTED THAT DURING THE ULTRASOUND MODE OF CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION), THERE WAS AN UNPLEASANT NOISE COMING FROM THE CASSETTE AND ROLLER AREA. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665188 ↗MalfunctionJun 27, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED DURING ULTRA SOUND MODE OF CATARACT SURGERY (WITH IOL INTRAOCULAR LENS IMPLANT). 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 19621451 ↗MalfunctionMay 3, 2024Suction Failure; Suction Failure
THE PHYSICIAN REPORTED THAT MESSAGE WAS DISPLAYED AND ASPIRATION FAILURE OCCURRED DURING ULTRASOUND SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237136 ↗MalfunctionApr 5, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER CASSETTE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056470 ↗MalfunctionApr 6, 2023Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION WAS STOPPED DURING ULTRASOUND, TRIED TO REPRIME BUT AN ERROR CODE WAS DISPLAYED WHICH WAS UNKNOWN, WITH NO HARM TO PATIENT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16689806 ↗
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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