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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/
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
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
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.