Recall Z-0028-05 ยท LPN Accessories, Soft Lens Products
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.
| Date | Oct 21, 2004 (initiated Sep 27, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031522 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION Ciba Vision Corporation, Jun 27, 2003 |