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U.S. Department of Health and Human Services

Class 3 Device Recall FreshLook, TORIC

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  Class 3 Device Recall FreshLook, TORIC see related information
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/
Ciba Vision Corporation
11460 Johns Creek Parkway
Duluth GA 30097
For Additional Information Contact Steve Strouphauer
Manufacturer Reason
for Recall
FDA Determined
Cause 2
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.