Recall Z-1706-2010 ยท LPM Lenses, Soft Contact, Extended Wear
Ciba Vision Corporation
AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric lenses approved for daily wear and extended wear up to 6 nights.
| Date | May 27, 2010 (initiated Apr 27, 2010) |
| Status | Terminated |
| Reason | The lenses inside the package do not match the prescription information for power labeled on the primary package. |
| Root cause | Packaging process control |
| Action | CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm. For further information, contact your CIBA Vision sales representative or call 1-877-542-5928. |
| Quantity | Lot #8717082, total 5040 lenses and Lot #8717066 total 5394 lenses |
| Distribution | Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.