Recall Z-0951-2015— 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 / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) 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, product is not sterile. 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 / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) 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, product is not sterile. 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.