Z-0950-2015Class II

Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1)...

Name: Z-0950-2015 Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1)...
Creator: Intertrade Imports Inc.
Published: 2014-09-10
License: https://open.fda.gov/license/

Intertrade Imports Inc. / initiated 2014-09-10 / Terminated / root cause: manufacturing process

FDA source

Intertrade Imports Inc. began a recall of Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and... on 2014-09-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0950-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-10
Posted: 2015-01-12
Terminated: 2019-10-07
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
Product code: LPM Lenses, Soft Contact, Extended Wear
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 750 units
Distribution: Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Product codes and lots: ALL LOTS / CODES

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0950-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12
Z-0951-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)