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Z-0642-2012

Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with...

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

Eyezone began a recall of Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads, NeuLook COLOR CONTACT... 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-0642-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eyezone
Product
Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads, NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Lens, 38% water and 62% Polymacon immersed in saline. Caution : To ensure that your contacts stay comfortable and your vision stay clear, ask your eye-care professional for product instruction. ***DIA. 14.0mm B.C 8.6mm***Rxonly STERILE***FDA 510K Cleared Made in Korea***Power : Plane Color : Blue Angelic The color contact lens colors are: Aqua, blue, blue sapphire, dark gray, dark violet, gray, green, hazel, honey, jade, magic angel, misty blue, misty green, misty hazel, pearl gray, pure hazel, sky blue, sweet gray, turquoise, violet, black out, vein, night, white cat, red cat devil, blue angelic, white out, hot red spider web, psycho, cruller, solid yellow, and blue wheel. 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: BD54 EXP 2014/09, include all lots, Barcode on label: Bottle: No barcode, Box: 8 806048 000468.