Recall Z-1756-2010 ยท LPM Lenses, Soft Contact, Extended Wear
Kim's Trading Inc
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.
| Date | Jun 4, 2010 (initiated May 17, 2010) |
| Status | Terminated |
| Reason | Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices. |
| 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 | 300 pairs of contact lens |
| Distribution | All product was distributed to one distributor in the Bethlehem PA area. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.