Recall Z-0642-2012 ยท LPL Lenses, Soft Contact, Daily Wear
Eyezone
Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads, NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Lens, 38% water and 62% Polymacon immersed in saline. Caution : To ensure that your contacts stay comfortable and your vision stay clear, ask your eye-care professional for product instruction. ***DI
| Date | Jan 11, 2012 (initiated Dec 5, 2011) |
| Status | Terminated |
| Reason | This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded. |
| Root cause | Labeling False and Misleading |
| Action | Pishon Trading sent an Urgent Medical Device Recall letter dated November 9, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to examine their inventory and quarantine the recalled product, and they were instructed to return the recalled products to Pishon Trading. Customers were instructed to complete and return the enclosed response form as soon as possible. If customers had any questions, they can call (562) 906-1100. On December 16, 2011, Pishon Trading expanded their r |
| Quantity | 24,628 total pairs |
| Distribution | Nationwide Distribution including LA, MS, NV, CA, TX, TN, AR, HI, IL, GA, and FL.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002099 | S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- Bescon Co., Ltd., Jul 9, 2001 |