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U.S. Department of Health and Human Services

Class 2 Device Recall Neulook

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  Class 2 Device Recall Neulook see related information
Date Initiated by Firm December 05, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-0643-2012
Recall Event ID 60633
510(K)Number K002099  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
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
Code Information LOT. BD53, EXP. 2014/08, 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
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
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.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = BESCON CO., LTD.
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