BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.

    Recall: Z-1947-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1947-2014
    Event ID
    68335
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 9, 2014
    Initiation Date
    May 16, 2014
    Classification Date
    June 30, 2014
    Termination Date
    December 9, 2014
    Address
    6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.

    Reason

    Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

    Code Info

    Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.

    Distribution

    Nationwide Distribution including North Carolina and Maine

    Quantity

    684 total (525 units in US)