FDA Medical Device Recalls (openFDA)
Ciba Vision Corporation: AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric lenses approved for daily wear and extended wear up to 6 nights.
- Recall number
- Z-1706-2010
- Recalling firm
- Ciba Vision Corporation
- Product
- AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric lenses approved for daily wear and extended wear up to 6 nights.
- Status
- Terminated
- Initiated
- 2010-04-27
- Posted
- 2010-05-27
- Terminated
- 2010-10-22
- Reason
- The lenses inside the package do not match the prescription information for power labeled on the primary package.
- Root cause
- Packaging process control
- Action
- CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm. For further information, contact your CIBA Vision sales representative or call 1-877-542-5928.
- Quantity
- Lot #8717082, total 5040 lenses and Lot #8717066 total 5394 lenses
- Distribution
- Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI.
- Lot, serial or model codes
- Lot Number: 8717082, Exp. 10/2013, Label Power: -0.50, Cylinder: -1.75, Axis: 180; and Lot Number: 8717066, Exp. 10/2013, Label Power: -2.50, Cylinder -1.75, Axis 180.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010019S011"]
- Product code
- LPM
- 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