Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AIR OPTIX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall AIR OPTIX see related information
Date Initiated by Firm April 27, 2010
Date Posted May 27, 2010
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-1706-2010
Recall Event ID 55570
PMA Number P010019S011 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
Product 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.
Code Information Lot Number: 8717082, Exp. 10/2013, Label Power: -0.50, Cylinder: -1.75, Axis: 180; and Lot Number: 8717066, Exp. 10/2013, Label Power: -2.50, Cylinder -1.75, Axis 180. 
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097
For Additional Information Contact Joseph (Skip) Burke
678-415-3350
Manufacturer Reason
for Recall		 The lenses inside the package do not match the prescription information for power labeled on the primary package.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPM and Original Applicant = Alcon Laboratories, Inc.
-
-