Z-1756-2010
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered...
Kim's Trading Inc / initiated 2010-05-17 / Terminated
Kim's Trading Inc began a recall of 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... on . The reason FDA records is "Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1756-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Kim's Trading Inc
- 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.
- Product code
- LPM Lenses, Soft Contact, Extended Wear
- Reason for recall
- Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
- FDA root cause
- PMA
- 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.
- Product codes and lots
- 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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
