BEUDAMED
    FDA Recall Terminated

    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

    Recall: Z-0929-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0929-2013
    Event Number
    64015
    Firm
    Abbott Medical Optics Inc (AMO)
    FEI Number
    3003843509
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 20, 2012
    Posted
    March 9, 2013
    Terminated
    January 8, 2014
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

    Reason

    Two production orders of these IOLs that contain mislabeled IOLs.

    Action

    AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.

    Distribution

    Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.

    Quantity

    155 units