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Class 3 Device Recall FreshLook Enhancers |
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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
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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/ Manufacturer |
Ciba Vision Corporation 11440 Johns Creek Pkwy Duluth GA 30097-1518
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For Additional Information Contact |
Gina Ingraham 678-415-4088
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Manufacturer Reason for Recall |
The lens inside the package does not match the prescription information labeled on the primary package.
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FDA Determined Cause 2 |
Other |
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
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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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