Events

Recall of Device Recall Neulook

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eyezone.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60633
  • Event Risk Class
    Class 2
  • Event Number
    Z-0642-2012
  • Event Initiated Date
    2011-12-05
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106090
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lenses, soft contact, daily wear - Product Code LPL
  • Reason
    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.
  • 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.

Device

Device Recall Neulook
  • Model / Serial
    LOT: BD54 EXP 2014/09, include all lots, Barcode on label: Bottle: No barcode, Box: 8 806048 000468.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including LA, MS, NV, CA, TX, TN, AR, HI, IL, GA, and FL..
  • Product Description
    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
  • Manufacturer
    Eyezone

Manufacturer

Eyezone
  • Manufacturer Address
    Eyezone, 10600 Shoemaker Ave Ste C, Santa Fe Springs CA 90670-4073
  • Source
    USFDA