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U.S. Department of Health and Human Services

Class 3 Device Recall Quick Care Starting Solution

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  Class 3 Device Recall Quick Care Starting Solution see related information
Date Initiated by Firm August 13, 2003
Date Posted September 13, 2003
Recall Status1 Terminated 3 on January 28, 2005
Recall Number Z-1234-03
Recall Event ID 26932
PMA Number P900029 
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.
Code Information Lot No. 1278080, exp. date 5/2004
Recalling Firm/
Manufacturer
Ciba Vision Corporation
11440 Johns Creek Parkway
Duluth GA 30097
For Additional Information Contact Steve Strouphauer
678-415-3388
Manufacturer Reason
for Recall
Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.
FDA Determined
Cause 2
Other
Action The consignees were notified of the recall by letter on August 13, 2003 asking for return of the product.
Quantity in Commerce 2,136 units
Distribution CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI
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.
PMA Database PMAs with Product Code = LPN and Original Applicant = CIBA VISION CORPORATION
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