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U.S. Department of Health and Human Services

Class 2 Device Recall Fancy i Color cosmetic lens

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 Class 2 Recall
Fancy i Color cosmetic lens
see related information
Date Posted June 04, 2010
Recall Status1 Terminated on August 11, 2010
Recall Number Z-1756-2010
Recall Event ID 55807
Product Classification Lenses, Soft Contact, Extended Wear - Product Code LPM
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Kim's Trading Inc
509 Wyandotte St
Bethlehem, Pennsylvania 18015-1525
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Min Kim
201-674-7111
Manufacturer Reason
for Recall
Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
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.
Quantity in Commerce 300 pairs of contact lens
Distribution All product was distributed to one distributor in the Bethlehem PA area.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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