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.
This recall has been terminated (originally issued December 18, 2002).
- Company
- Ciba Vision Corporation
- Recall Initiated
- November 12, 2002
- Posted
- December 18, 2002
- Terminated
- April 28, 2003
- Recall Number
- Z-0342-03
- Quantity
- 559 vials (one lens per vial)
- Firm Location
- Duluth, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Lenses were labeled with the wrong prescription.
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.
Lot / Code Info
Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power -1.50.
Root Cause
Other
Action Taken
In the United States, CIBA Vision contacted accounts via traceable letter on 11/12/2002 with attached Business Reply Card form.
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