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Z-0643-2012

Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads...

Eyezone / initiated 2011-12-05 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Eyezone began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0643-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eyezone
Product
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
Product code
LPL Lenses, Soft Contact, Daily Wear
Reason for recall
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.
Root cause tag
labeling and UDI
FDA root cause
Labeling False and Misleading
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.
Quantity in commerce
24,628 total pairs
Distribution
Nationwide Distribution including LA, MS, NV, CA, TX, TN, AR, HI, IL, GA, and FL..
Product codes and lots
LOT. BD53, EXP. 2014/08, include all Lots, Barcode on label: Bottle: No barcode, box: 8 806048 000468.