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U.S. Department of Health and Human Services

Class 3 Device Recall FreshLook Enhancers

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  Class 3 Device Recall FreshLook Enhancers 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-0742-04
Recall Event ID 28542
Product Classification Lenses, Soft Contact, Extended Wear - Product Code LPM
Product FreshLook¿ Enhancers, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -0.75, LOT ***, 2008-06, WJ¿, Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plaines, IL 60018 USA, Made in USA. Product is packed in 6 packs
Code Information Lot #085612, Exp. Date: 2008-06, Lot #095007, Exp. Date: 2008-06, Lot #098003, Exp. Date 2008-06.
Recalling Firm/
Ciba Vision Corporation
11440 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
Manufacturer Reason
for Recall
The lens inside the package does not match the prescription information labeled on the primary package.
FDA Determined
Cause 2
Action Consignees were notified by letter on 3/11/2004.
Quantity in Commerce 353/6pk
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.