Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Neulook

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-0642-2012
Recall Event ID 60633
510(K)Number K002099  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
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
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.
-
-