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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 Device Recall Fancy i Color cosmetic lenssee related information
Date Initiated by FirmMay 17, 2010
Date PostedJune 04, 2010
Recall Status1 Terminated 3 on August 11, 2010
Recall NumberZ-1756-2010
Recall Event ID 55807
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductFancy 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 PA 18015-1525
For Additional Information ContactMin 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		PMA
ActionKim'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 Commerce300 pairs of contact lens
DistributionAll product was distributed to one distributor in the Bethlehem PA area.
Total Product Life CycleTPLC 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.
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