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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 21, 2005
Create Date June 25, 2015
Recall Status1 Terminated 3 on October 21, 2005
Recall Number Z-0847-05
Recall Event ID 31864
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product Fresh Look * Radiance¿ * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses.
Code Information Lot #124637
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
678-415-4088
Manufacturer Reason
for Recall		 The actual power of the lenses may be different from what is indicated on the package labeling.
FDA Determined
Cause 2		 Other
Action Consignees were notified via traceable mail on April 21, 2005.
Quantity in Commerce 2250 units
Distribution Nationwide, Europe
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.
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