Z-0342-03

Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH...

Name: Z-0342-03 Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH...
Creator: Ciba Vision Corporation
Published: 2002-11-12
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2002-11-12 / Terminated / root cause: labeling and UDI

FDA source

Ciba Vision Corporation began a recall of 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... on 2002-11-12. The reason FDA records is "Lenses were labeled with the wrong prescription". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0342-03
Status: Terminated
Initiated: 2002-11-12
Posted: 2002-12-18
Terminated: 2003-04-28
Recalling firm: Alcon Laboratories
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Lenses were labeled with the wrong prescription.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power -1.50.

Product code LPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)