CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Labeled in part: I Color Complete / Color Lens recalled
Intertrade Imports is recalling Labeled in part: I Color Complete / Color Lens, blister packing (Additional colors, distributed in California, Florida, Texas. The recall was initiated on 10 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0950-2015
- FDA event ID
- 69419
- Recalling firm
- Intertrade Imports, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2014
- FDA classified
- 12 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Bacterial Contamination
- Device type
- Contact Lenses & Eye Devices
Timeline
| 10 Sep 2014 | Recall initiated by company | |
| 12 Jan 2015 | Classified by FDA | +124 days |
| 21 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
ALL LOTS / CODES
Where was it sold?
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69419| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Labeled in part: I Color Complete / Crazy Lens recalled | Intertrade Imports | Other Bacterial Contamination | CA, FL, TX |
More recalls from Intertrade Imports
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Labeled in part: I Color Complete / Crazy Lens recalled | Intertrade Imports | Other Bacterial Contamination | CA, FL, TX |
Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |