LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT CBL-2000Recalls & reported problems
Tearscience, Inc. · KIT CABLE PKGD ACTIVATOR II - US · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859623006711), received between Dec 18, 2019 and Nov 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition 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
- Thermal Decomposition of Device2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THE CABLES ARE BURNING OUT AND THEY ARE TURNING DARK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10871414 ↗MalfunctionDec 18, 2019Thermal Decomposition of Device; Thermal Decomposition of Device
ACCOUNT REPORTED THAT CABLE HAD BURN MARKS ON IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9491975 ↗
Other Eyelid thermal pulsation system devices
- LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE LFD-2000Tearscience, Inc. · Eyelid thermal pulsation system6 reports
- LIPIFLOW SYSTEM CONSOLE LFTP-1000Tearscience, Inc. · Eyelid thermal pulsation system2 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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