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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmOctober 13, 2004
Create DateNovember 03, 2004
Recall Status1 Terminated 3
Recall NumberZ-0164-05
Recall Event ID 30238
ProductCounterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.
Recalling Firm/
Manufacturer		 1-800 Contacts Inc.
66 Wadsworth Park Dr
Draper UT 84020-7942
For Additional Information ContactRoy Montclair
801-924-9613
Manufacturer Reason
for Recall		Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.
ActionIdentified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.
Quantity in Commerce82,268
DistributionProduct distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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