|
Class 3 Device Recall FreshLook, TORIC |
|
Date Initiated by Firm |
December 16, 2002 |
Date Posted |
December 31, 2002 |
Recall Status1 |
Terminated 3 on August 07, 2003 |
Recall Number |
Z-0405-03 |
Recall Event ID |
25221 |
PMA Number |
P830037 |
Product Classification |
Lenses, Soft Contact, Extended Wear - Product Code LPM
|
Product |
FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.
|
Code Information |
049007 and 041599 |
Recalling Firm/ Manufacturer |
Ciba Vision Corporation 11460 Johns Creek Parkway Duluth GA 30097
|
For Additional Information Contact |
Steve Strouphauer 678-415-3388
|
Manufacturer Reason for Recall |
Mislabeling
|
FDA Determined Cause 2 |
Other |
Action |
Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone. |
Quantity in Commerce |
35 units (multi-pack/six lenses per unit). |
Distribution |
01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved.
CIBA Vision Canada, Ontario, Canada. |
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.
|
|
|
|