BEUDAMED
    FDA Recall Terminated

    Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

    Recall: Z-0275-2012 · Initiated September 20, 2011

    Recall

    Recall Number
    Z-0275-2012
    Event Number
    59980
    Firm
    Abbott Medical Optics Inc (AMO)
    FEI Number
    3003843509
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 20, 2011
    Posted
    November 23, 2011
    Terminated
    January 8, 2014
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

    Reason

    The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.

    Action

    Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. For any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative. For any questions regarding this recall call 714-247-8656.

    Distribution

    Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia

    Quantity

    83