Recall Z-0950-2015— Intertrade Imports Inc.
Class II · Terminated
Class II FDA medical device recall by Intertrade Imports Inc., initiated 2014-09-10, terminated 2019-10-07. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Intertrade Imports Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-10
- Terminated
- 2019-10-07
- Firm location
- Jacksonville, FL, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.