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Terminated

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.

FDA Recall Z-0342-03 · Posted 2002-12-18

Recall StatusTerminated
Product CodeLPL
Date Initiated2002-11-12
Date Terminated2003-04-28
Product Quantity559 vials (one lens per vial)

Reason for Recall

Lenses were labeled with the wrong prescription.

Firm Action

In the United States, CIBA Vision contacted accounts via traceable letter on 11/12/2002 with attached Business Reply Card form.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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