FDA Medical Device Recalls (openFDA)
Ciba Vision Corporation: 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.
- Recall number
- Z-0342-03
- Recalling firm
- Ciba Vision Corporation
- 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.
- Status
- Terminated
- Initiated
- 2002-11-12
- Posted
- 2002-12-18
- Terminated
- 2003-04-28
- Reason
- Lenses were labeled with the wrong prescription.
- 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
- 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.
- Lot, serial or model codes
- Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power -1.50.
- 510(k) numbers
- not on file
- PMA numbers
- ["P820086"]
- Product code
- LPL
- Firm FEI
- 1053053
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28