Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
FDA Recall Z-1404-2017 · Posted None
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Recalling FirmThe See Clear Company
Recall StatusOpen, Classified
Product CodeLPL
Date Initiated2017-01-06
Product Quantity119,829 units
Reason for Recall
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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