BEUDAMED
    FDA Recall Terminated

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.

    Recall: Z-1123-2014 · Initiated January 28, 2014

    Recall

    Recall Number
    Z-1123-2014
    Event Number
    67385
    Firm
    AMO Puerto Rico Manufacturing, Inc.
    FEI Number
    2648035
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 28, 2014
    Posted
    March 3, 2014
    Terminated
    April 19, 2017
    Address
    Rd # 402, Km 4.2, Anasco, PR, 00610

    Description

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.

    Reason

    Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

    Action

    Beginning on January 28, 2014, AMO began distribution of the Recall Notification Letter to the 72 AMO TECNIS IOL customer accounts within the United States who had received lenses from the 2 affected P/O's. 100% delivery of the recall communication to US customers was confirmed on January 31, 2014. Included with the Recall Notification Letter is a facsimile delivery confirmation which each customer is instructed to fax back to AMO.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.

    Quantity

    169 units