Recall of Device Recall Fancy i Color cosmetic lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kim's Trading Inc.

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
    55807
  • Event Risk Class
    Class 2
  • Event Number
    Z-1756-2010
  • Event Initiated Date
    2010-05-17
  • Event Date Posted
    2010-06-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2010-08-11
  • Event Source
    USFDA
  • Event Source URL
  • 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, extended wear - Product Code LPM
  • Reason
    Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
  • Action
    Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed. For further information, contact Kim's Trading Inc. at 1-484-895-3773.

Device

  • Model / Serial
    Lot Number D01704: includes models Amber, Amethyst, Blueberry Crush, BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21, HL22, HL23, HL24, HL26, Fierce Fandango and Holiday Green; Lot Number D01711: inlcudes models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and Natural Hazel; Lot Number D01712: includes models Aquamist, Artic Blue, Deep Ocean Blue, HJ35, HJ36 and HW26; Lot Number D01713: includes models HJ33, HJ34, HW23, HW24, Lavender, Lazer Green, Sour Apple Green and Vibrant Violet; and Lot (unidentified): includes models 011, 015, 024, 029, 032, 033, 035, 043-1, 044, 046, 047, 049, 055, 063-1, 064, 071, 079, 085 and 088.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    All product was distributed to one distributor in the Bethlehem PA area.
  • Product Description
    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Kim's Trading Inc, 509 Wyandotte St, Bethlehem PA 18015-1525
  • Source
    USFDA