BEUDAMED
    FDA Recall Terminated

    Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR CONTACT LENSES Give yourself a whole new look***LENS CASE INCLUDED HOT RED PWR. 0.00 LOT. BD53***EXP. 2014/08***Contents : Two sterile color contact lenses(62% Polymacon, 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear, ask your eye-care professional for product instruction. Made in Korea www.NeuLooklens.com Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468. The color contact lens colors are: Black out, vein, night, white cat, red cat devil, blue angelic, white out, and hot red. prescription contact lens

    Recall: Z-0643-2012 · Initiated December 5, 2011

    Recall

    Recall Number
    Z-0643-2012
    Event Number
    60633
    Firm
    Eyezone
    FEI Number
    3009014092
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 5, 2011
    Posted
    January 11, 2012
    Terminated
    September 4, 2014
    Address
    10600 Shoemaker Ave, Ste C, Santa Fe Springs, CA, 90670-4073

    Description

    Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR CONTACT LENSES Give yourself a whole new look***LENS CASE INCLUDED HOT RED PWR. 0.00 LOT. BD53***EXP. 2014/08***Contents : Two sterile color contact lenses(62% Polymacon, 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear, ask your eye-care professional for product instruction. Made in Korea www.NeuLooklens.com Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468. The color contact lens colors are: Black out, vein, night, white cat, red cat devil, blue angelic, white out, and hot red. prescription contact lens

    Reason

    This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.

    Action

    Pishon Trading sent an Urgent Medical Device Recall letter dated November 9, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to examine their inventory and quarantine the recalled product, and they were instructed to return the recalled products to Pishon Trading. Customers were instructed to complete and return the enclosed response form as soon as possible. If customers had any questions, they can call (562) 906-1100. On December 16, 2011, Pishon Trading expanded their recall by sending a new recall letter to all their customers who purchased the Neulook Deluxe and Neulook Fancy contact lens to include all lots.

    Distribution

    Nationwide Distribution including LA, MS, NV, CA, TX, TN, AR, HI, IL, GA, and FL..

    Quantity

    24,628 total pairs