Recall Z-1404-2017 ยท LPL Lenses, Soft Contact, Daily Wear
The See Clear Company
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
| Date | Jan 6, 2017 |
| Status | Open, Classified |
| Reason | Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates. |
| Root cause | Device Design |
| Action | The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstan |
| Quantity | 119,829 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111345 | SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS The See Clear Company, Inc., Nov 2, 2011 |