FDA Medical Device Recalls (openFDA)
The See Clear Company: Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
- Recall number
- Z-1404-2017
- 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.
- Status
- Open, Classified
- Initiated
- 2017-01-06
- Posted
- not on file
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- All lots of lenses sold between 10/31/2013 to 10/31/2016
- 510(k) numbers
- ["K111345"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 3009384112
- Firm city
- Peachtree Corners
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28