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U.S. Department of Health and Human Services

Class 3 Device Recall Focus DAILIES

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  Class 3 Device Recall Focus DAILIES see related information
Date Initiated by Firm July 25, 2006
Date Posted August 16, 2006
Recall Status1 Terminated 3 on December 27, 2006
Recall Number Z-1402-06
Recall Event ID 35990
510(K)Number K050065  
Product Classification Soft contact lenses - Product Code LPL
Product Focus¿ * DAILIES¿ * Toric * One-Day Contact Lenses * CIBA Vision
Code Information Lot #6118348 (5 pack), 6110170 (30 pack) and 6110210 (30 pack)
Recalling Firm/
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
Manufacturer Reason
for Recall
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
FDA Determined
Cause 2
Action Consignees were notified by letter on/about 07/25/06 to return any of the affected lots found in inventory
Quantity in Commerce 86 (approx 1000 lenses) packs total
Distribution Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA.
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.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = CIBA VISION CORPORATION