BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEPHEX

    MDR report key: 24254591 · Received February 3, 2026

    Report

    Report Number
    3010351679-2026-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    September 9, 2024
    Manufacturer
    BLEPHEX, LLC
    Product Code
    PYU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    THE COMPLAINT RELATES TO THE BLEPHEX BATTERY-POWERED EYELID CLEANING SPONGE THAT CONSISTS OF A HANDPIECE THAT SPINS A SMALL SOFT SPONGE IN THE HORIZONTAL AXIS. THE MICRO-SPONGE IS APPLIED TO THE LOWER AND UPPER LID EDGES AND LASH LINES. THE HANDPIECE HAS A LITHIUM-ION BATTERY THAT IS CHARGED IN A PLASTIC CHARGING STATION. THE HANDPIECE IS CHARGED BETWEEN USES AND THE CHARGER ITSELF IS NOT PATIENT CONTACTING. BLEPHEX, LLC MANUFACTURED A LIMITED, SPECIAL BATCH OF EXTERNAL POWER CHARGERS EQUIPPED WITH TYPE G (UK) PLUGS FOR A SINGLE AUTHORIZED RESELLER IN THE UNITED KINGDOM. THESE CHARGERS WERE PRODUCED AND SOLD EXCLUSIVELY TO THIS RESELLER IN 2014 AND WERE NOT DISTRIBUTED TO ANY OTHER CUSTOMERS OR MARKETS. ONLY THIS RESELLER RECEIVED THIS SPECIFIC CONFIGURATION. BLEPHEX, LLC RECEIVED THIS COMPLAINT FROM THE RESELLER BASED ON A REPORT FROM THE END-USER OPHTHALMOLOGY CLINIC IN THE UNITED KINGDOM REPORTING THAT THE CHARGER USED WITH THE BLEPHEX POWERED EYELID SPONGE BEGAN OVERHEATING, SMOKING, OR EXPERIENCED A SUDDEN ELECTRICAL FAILURE DESCRIBED BY THE USERS AS HAVING "BLOWN UP." NO INJURIES WERE REPORTED IN RELATION TO THESE THIS COMPLAINT. AS A CORRECTIVE AND PREVENTIVE ACTION, IN NOVEMBER 2024 BLEPHEX, LLC SUPPLIED THE UK RESELLER WITH 190 NEWLY MANUFACTURED REPLACEMENT CHARGERS UTILIZING A USB-BASED POWER CONFIGURATION. THE RESELLER WAS INSTRUCTED TO REMOVE ALL REMAINING TYPE G CHARGERS FROM SERVICE AND REPLACE ANY CHARGERS STILL IN THE FIELD WITH THE UPDATED UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600317 BLEPHEX POWERED EYELID CLEANIMG SPONGE PYU BLEPHEX, LLC BLEPHEX CHARGER - TYPE G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown