Known Identifiers & Locations
FEI Numbers
1053053
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (4)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0018-07 |
CSI Daily Wear, soft (hydrophilic) contact lenses
Reason: Out of specification lens curve
|
2006-09-13 |
Terminated
|
View Details
|
| Z-0019-07 |
CSI Flexible Wear, soft (hydrophilic) contact lenses
Reason: Out of specification lens curve
|
2006-09-13 |
Terminated
|
View Details
|
| Z-0020-07 |
CSI Toric, soft (hydrophilic) contact lenses
Reason: Out of specification lens curve
|
2006-09-13 |
Terminated
|
View Details
|
| Z-0028-05 |
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.
Reason: Stability tests at 24 months revealed failing results for disinfection efficacy.
|
2004-09-27 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.