OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per pa
FDA device recall Z-0427-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Ciba Vision Corporation
- Reason for recall
- Reduced Ion Permeability
- Action taken
- Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPM
- Quantity affected
- 11.4 million lenses
- Distribution
- Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany
- Date initiated
- 2007-01-11
- Date posted
- 2007-02-15
- Date terminated
- 2008-03-21
- Location
- Duluth, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS (K033919) | Ciba Vision Corporation | 2004-03-12 |