Recall Z-0427-2007 ยท LPM Lenses, Soft Contact, Extended Wear
Ciba Vision Corporation
OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).
| Date | Feb 15, 2007 (initiated Jan 11, 2007) |
| Status | Terminated |
| Reason | Reduced Ion Permeability |
| Root cause | Other |
| Action | 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. |
| Quantity | 11.4 million lenses |
| Distribution | Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033919 | CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS Ciba Vision Corporation, Mar 12, 2004 |