BEUDAMED
    FDA Recall Terminated

    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

    Recall: Z-0271-2016 · Initiated September 29, 2015

    Recall

    Recall Number
    Z-0271-2016
    Event Number
    72377
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 29, 2015
    Posted
    November 25, 2015
    Terminated
    June 30, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

    Reason

    Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.

    Action

    The firm, Alcon, sent an "FDA Notification-Update to Recall Z-2323-2015" letter, dated October 1, 2015, to its Consignee in Japan who have received AcrySof IQ Toric IOL models SN6AT6 to SN6AT9 in order to initiate the recovery of product. The letter described the product, problem and actions to be taken. The consignee was instructed to stop using these immediately and put on hold until sales representatives visit their site for withdrawal. Recall does not affect AcrySof IQ Monofocal IOLs or AcrySof IQ Toric IOL models SN6AT3, SN6AT4 and SN6AT5.

    Distribution

    International Only Distribution -- Japan.

    Quantity

    43,651 units