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U.S. Department of Health and Human Services

Class 2 Device Recall CooperVision Contact Lenses

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 Class 2 Recall
CooperVision Contact Lenses
see related information
Date Posted November 03, 2004
Recall Status1 Open
Recall Number Z-0164-05
Recall Event ID 30238
Product Classification Lens, Contact, (Disposable) - Product Code MVN
Product Counterfeit 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***''.
Code Information (Identified as Lot number , power): 200218733K, -0.75; 200221583L, -1.00; 200221758L, -1.25; 200217599K, -1.50; 200219058K; -1.75; 200203444G, -2.00; 200217595K, -2.25; 200221190L, -2.50; 200219740K, -2.75; 200217588K, -3.00; 200323296A, -3.25; 200222445L, -3.50; 200325268A, -3.75; 200292234E, -4.00; 2002922484E, -4.00; 200213996J, -4.25; 200218908K, -4.50; 200214236J, -4.75; 200215709J, -5.00; 200212242J, -5.25; 200325303A, -5.50; 200213136J, -5.75; 200213135J, -6.00; 200208401H, -6.50; 200219479K, -7.00; and 200218545K, -7.50.
Recalling Firm/
Manufacturer
1-800 Contacts Inc.
66 Wadsworth Park Dr
Draper, Utah 84020-7942
For Additional Information Contact Roy Montclair
801-924-9613
Manufacturer Reason
for Recall
Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.
Action Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.
Quantity in Commerce 82,268
Distribution Product 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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