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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 Device Recall CooperVision Contact Lenses see related information
Date Initiated by Firm October 13, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on February 25, 2005
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 UT 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.
FDA Determined
Cause 2		 Other
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 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.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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