BEUDAMED
    FDA Recall Terminated

    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

    Recall: Z-2323-2015 · Initiated April 15, 2015

    Recall

    Recall Number
    Z-2323-2015
    Event Number
    71630
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 15, 2015
    Posted
    August 7, 2015
    Terminated
    June 30, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

    Reason

    There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

    Action

    Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.

    Distribution

    Distribution Japan, No US distribution.

    Quantity

    45,391