BEUDAMED
    FDA Enforcement Class I 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 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2323-2015
    Event ID
    71630
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    April 15, 2015
    Classification Date
    August 7, 2015
    Termination Date
    June 30, 2017
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    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.

    Code Info

    Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

    Distribution

    Distribution Japan, No US distribution.

    Quantity

    45,391