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.
FDA Recall Z-0028-05 · Posted 2004-10-21
Recalling FirmCiba Vision Corporation
Recall StatusTerminated
Product CodeLPN
Date Initiated2004-09-27
Date Terminated2005-08-22
Product Quantity5,913,120 units
Reason for Recall
Stability tests at 24 months revealed failing results for disinfection efficacy.
Firm Action
Consignees were notified by letter on 10/01/2004.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.