BEUDAMED
    FDA Recall 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 · Initiated May 16, 2014

    Recall

    Recall Number
    Z-1947-2014
    Event Number
    68335
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 16, 2014
    Posted
    June 30, 2014
    Terminated
    December 9, 2014
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    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

    Action

    Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email [email protected]. Customers with questions were instructed to call 1-800-862-5266.

    Distribution

    Nationwide Distribution including North Carolina and Maine

    Quantity

    684 total (525 units in US)