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U.S. Department of Health and Human Services

Class 3 Device Recall FreshLook Colors

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  Class 3 Device Recall FreshLook Colors see related information
Date Initiated by Firm March 11, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 16, 2005
Recall Number Z-0741-04
Recall Event ID 28542
Product Classification Lenses, Soft Contact, Extended Wear - Product Code LPM
Product FreshLook¿ Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)
Code Information Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date 2006-11, Lot #065530, Exp. Date 2006-11, Lot #079803, Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot #0-65427, Exp. Date: 2006-11.
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11440 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
678-415-4088
Manufacturer Reason
for Recall		 The lens inside the package does not match the prescription information labeled on the primary package.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 3/11/2004.
Quantity in Commerce 3141/6pk, 1000/2pk & 1720/single trial
Distribution Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
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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