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/ 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 |
Lack of assurance of sterility at the time of manufacture.
|
FDA Determined Cause 2 |
Other |
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
|