Class 3 Device Recall FreshLook Colors

• Date Initiated by Firm: March 11, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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.