| Class 2 Device Recall CIBAVision, CIBASOFT Visitint. | |
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
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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 |
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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.
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PMA Database | PMAs with Product Code = LPL
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