BEUDAMED
    FDA Enforcement Class I Terminated

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

    Recall: Z-0186-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0186-2019
    Event ID
    80931
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    August 28, 2018
    Classification Date
    October 23, 2018
    Termination Date
    December 18, 2020
    Address
    714 Columbia Ave, N/A, Sinking Spring, PA, 19608-1405, United States

    Description

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

    Reason

    Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

    Code Info

    GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Uruguay.

    Quantity

    14264 units