Recall Z-1404-2017— The See Clear Company

Name: FDA recall Z-1404-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-06

Class II · Ongoing

Class II FDA medical device recall by The See Clear Company, initiated 2017-01-06. It names one FDA 510(k) clearance: K111345. Product: Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.. Reason: Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates..

Recalling firm: The See Clear Company
Classification: Class II
Status: Ongoing
Initiated: 2017-01-06
Firm location: Peachtree Corners, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K111345 — SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENSThe See Clear Company, Inc.·cleared 2011-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

Reason for recall

Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.