Z-1404-2017Class II

Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection...

Name: Z-1404-2017 Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection...
Creator: The See Clear Company
Published: 2017-01-06
License: https://open.fda.gov/license/

The See Clear Company / initiated 2017-01-06 / Open, Classified / root cause: design

FDA source

The See Clear Company began a recall of Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear on 2017-01-06. FDA classified it as Class II and gives the reason as "Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1404-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-01-06
Posted: 2017-03-03
Recalling firm: The See Clear Company
Product: Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
Root cause tag: design
FDA 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 outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.
Quantity in commerce: 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.
Product codes and lots: All lots of lenses sold between 10/31/2013 to 10/31/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1404-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code LPL

K111345Class IISee Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact LensThe See Clear Company, Inc. / cleared 2011-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)