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Recall Observatory FDA recall evidence

Device product

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

Z-1404-2017

January 06, 2017

Class II

Product summary

Firm
The See Clear Company
Event
Event 76279
Status
Ongoing
Classification
Class II
Quantity
119,829 units
Official record key
device-enforcement:Z-1404-2017

Official wording

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

Code information: All lots of lenses sold between 10/31/2013 to 10/31/2016

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Misbranding