Tearscience Recalls LipiFlow Thermal Pulsation System Activators Due to Error Condition
Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators because the device may automatically stop treatment during patient use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error (automatic stop) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators (Lot 201615220020). The LipiFlow Thermal Pulsation System is a prescription medical device intended for use by physicians to apply localized heat and pressure therapy to adult patients with chronic cystic conditions of the eyelids, such as meibomian gland dysfunction.
The recall was initiated due to complaints regarding an error condition where the system automatically stopped treatment after detecting a problem with the Activator. The affected units were distributed in the United States, including specific states and Puerto Rico.
Physicians and patients who have used or possess the affected Activators should contact Tearscience, Inc. for further instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this error condition.
The recalled product
- Product
- LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic…
- Manufacturer
- Tearscience, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 201615220020
Distribution
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