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U.S. Department of Health and Human Services

Class 2 Device Recall AQuify

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  Class 2 Device Recall AQuify see related information
Date Initiated by Firm November 02, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on June 19, 2006
Recall Number Z-0182-06
Recall Event ID 33960
510(K)Number K013204  
Product Classification Products, Contact Lens Care, Rigid Gas Permeable - Product Code MRC
Product AQuify¿ Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA
Code Information Lot #52246
Recalling Firm/
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
Manufacturer Reason
for Recall
Lack of assurance of sterility at the time of manufacture.
FDA Determined
Cause 2
Action Consignees were contacted by telephone with a follow up letter 11/04/2005.
Quantity in Commerce 29592 cases (24 units per case)
Distribution Nationwide, Canada, Germany, Benelux, and the UK
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 = MRC and Original Applicant = CIBA VISION CORPORATION