BEUDAMED
    FDA Recall Terminated

    Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

    Recall: Z-1575-05 · Initiated September 2, 2005

    Recall

    Recall Number
    Z-1575-05
    Event Number
    33409
    Firm
    Alcon Research, Ltd
    FEI Number
    1610287
    Product Code
    LQJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 2, 2005
    Posted
    September 21, 2005
    Terminated
    April 20, 2007
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2001

    Description

    Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

    Reason

    Unknown residue noted on suface of flap irrigators incorporated into cusom paks.

    Action

    Firm notified consignee by letter on 9/2/2005.

    Distribution

    Lake Charles, LA

    Quantity

    75 units