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U.S. Department of Health and Human Services

Class 3 Device Recall CIBA Vision contact lens

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  Class 3 Device Recall CIBA Vision contact lens see related information
Date Initiated by Firm January 17, 2003
Date Posted May 01, 2003
Recall Status1 Terminated 3 on May 01, 2003
Recall Number Z-0787-03
Recall Event ID 26077
PMA Number P830037 
Product Classification Lenses, Soft Contact, Extended Wear - Product Code LPM
Product FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
Code Information Lot number 064429, Expiration date, 2006/11  
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11440 Johns Creek Parkway
Duluth GA 30097
For Additional Information Contact Steve Stouphauer
678-415-3388
Manufacturer Reason
for Recall		 FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
FDA Determined
Cause 2		 Other
Action Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.
Quantity in Commerce 309/six pack cartons
Distribution The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.
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.
PMA Database PMAs with Product Code = LPM and Original Applicant = Alcon Laboratories, Inc.
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