BEUDAMED
    FDA Recall Terminated

    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

    Recall: Z-0185-2019 · Initiated August 28, 2018

    Recall

    Recall Number
    Z-0185-2019
    Event Number
    80931
    Firm
    Alcon Research, LTD.
    FEI Number
    2523835
    Product Code
    OGO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2018
    Posted
    October 23, 2018
    Terminated
    December 18, 2020
    Address
    714 Columbia Ave, Sinking Spring, PA, 19608-1405

    Description

    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 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.

    Action

    The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.

    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

    30561 units