Class 3 Device Recall FreshLook, TORIC

• Date Initiated by Firm: December 16, 2002
• Date Posted: December 31, 2002
• Recall Status: Terminated 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: 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.