| Class 2 Device Recall Neulook | |
Date Initiated by Firm | December 05, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on September 04, 2014 |
Recall Number | Z-0642-2012 |
Recall Event ID |
60633 |
510(K)Number | K002099 |
Product Classification |
Lenses, soft contact, daily wear - Product Code LPL
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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 |
Code Information |
LOT: BD54 EXP 2014/09, include all lots, Barcode on label: Bottle: No barcode, Box: 8 806048 000468. |
Recalling Firm/ Manufacturer |
Eyezone 10600 Shoemaker Ave Ste C Santa Fe Springs CA 90670-4073
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Manufacturer 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. |
FDA Determined Cause 2 | 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.. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LPL
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