FDA Medical Device Recalls (openFDA)
Intertrade Imports Inc.: 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
- Recall number
- Z-0950-2015
- Recalling firm
- Intertrade Imports Inc.
- 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
- Status
- Terminated
- Initiated
- 2014-09-10
- Posted
- 2015-01-12
- Terminated
- 2019-10-07
- 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.
- Root cause
- Material/Component Contamination
- Action
- The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.
- Quantity
- 750 units
- Distribution
- Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
- Lot, serial or model codes
- ALL LOTS / CODES
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPM
- Firm FEI
- 3007310352
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28