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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 September 27, 2004
Date Posted October 21, 2004
Recall Status1 Terminated 3 on August 22, 2005
Recall Number Z-0028-05
Recall Event ID 30159
510(K)Number K031522  
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product SOLO-care¿ Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Code Information All sizes, configurations and all third part branded products
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact CIBA Vision Custormer Service
800-541-2422
Manufacturer Reason
for Recall		 Stability tests at 24 months revealed failing results for disinfection efficacy.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 10/01/2004.
Quantity in Commerce 5,913,120 units
Distribution Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
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 = LPN and Original Applicant = CIBA VISION CORPORATION
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