FDA Medical Device Recalls (openFDA)
Ciba Vision Corporation: SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
- Recall number
- Z-0028-05
- Recalling firm
- Ciba Vision Corporation
- Product
- SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
- Status
- Terminated
- Initiated
- 2004-09-27
- Posted
- 2004-10-21
- Terminated
- 2005-08-22
- Reason
- Stability tests at 24 months revealed failing results for disinfection efficacy.
- Root cause
- Other
- Action
- Consignees were notified by letter on 10/01/2004.
- Quantity
- 5,913,120 units
- Distribution
- Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
- Lot, serial or model codes
- All sizes, configurations and all third part branded products
- 510(k) numbers
- ["K031522"]
- PMA numbers
- not on file
- Product code
- LPN
- 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