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Recall Observatory FDA recall evidence

Device product

Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens

Z-0950-2015

September 10, 2014

Class II

Product summary

Firm
Intertrade Imports Inc.
Event
Event 69419
Status
Terminated
Classification
Class II
Quantity
750 units
Official record key
device-enforcement:Z-0950-2015

Official wording

Reason: A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.

Code information: ALL LOTS / CODES

Distribution pattern: Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    presence of Bacillus Cereus