Z-0028-05

SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose...

Name: Z-0028-05 SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose...
Creator: Ciba Vision Corporation
Published: 2004-09-27
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2004-09-27 / Terminated

FDA source

Ciba Vision Corporation began a recall of SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation... on 2004-09-27. The reason FDA records is "Stability tests at 24 months revealed failing results for disinfection efficacy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0028-05
Status: Terminated
Initiated: 2004-09-27
Posted: 2004-10-21
Terminated: 2005-08-22
Recalling firm: Alcon Laboratories
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.
Product code: LPN Accessories, Soft Lens Products
Reason for recall: Stability tests at 24 months revealed failing results for disinfection efficacy.
FDA root cause: Other
Action: Consignees were notified by letter on 10/01/2004.
Quantity in commerce: 5,913,120 units
Distribution: Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
Product codes and lots: All sizes, configurations and all third part branded products

Product code LPN

K031522Class IISolo-Care Plus Multipurpose SolutionCiba Vision Corporation / cleared 2003-06-27

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)