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U.S. Department of Health and Human Services

Class 2 Device Recall CIBAVision, CIBASOFT Visitint.

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  Class 2 Device Recall CIBAVision, CIBASOFT Visitint. see related information
Date Initiated by Firm November 12, 2002
Date Posted December 18, 2002
Recall Status1 Terminated 3 on April 28, 2003
Recall Number Z-0342-03
Recall Event ID 25101
PMA Number P820086 
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH -1.50, CIBA Vision, Corp, Duluth, GA 30097, Made in USA.
Code Information Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power  -1.50.
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11460 Johns Creek Parkway
Duluth GA 30097
For Additional Information Contact Steve Strouphauer
678-415-3388
Manufacturer Reason
for Recall		 Lenses were labeled with the wrong prescription.
FDA Determined
Cause 2		 Other
Action In the United States, CIBA Vision contacted accounts via traceable letter on 11/12/2002 with attached Business Reply Card form.
Quantity in Commerce 559 vials (one lens per vial)
Distribution U.S. accounts: CA, GA, IL, MN, NJ, TX, VA. Foreign Distributors: Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Luxembourg, Moracco, Netherlands, Norway, Portugal, Spain, South Africa, Sweden, Switzerland and the United Arab Emirates. No government accounts involved.
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 = LPL and Original Applicant = CIBA VISION CARE
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