BEUDAMED
    FDA Enforcement Class II Ongoing

    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.

    Recall: Z-1888-2024 · Reported May 29, 2024

    Enforcement

    Recall Number
    Z-1888-2024
    Event ID
    94545
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2024
    Initiation Date
    April 3, 2024
    Classification Date
    May 23, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.

    Reason

    Potential for distal end of the sheath to break off during a procedure.

    Code Info

    Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.

    Quantity

    pending