Class 3 Device Recall Focus DAILIES

• Date Initiated by Firm: July 25, 2006
• Date Posted: August 16, 2006
• Recall Status: Terminated on December 27, 2006
• Recall Number: Z-1402-06
• Recall Event ID: 35990
• 510(K)Number: K050065
• Product Classification: Soft contact lenses - Product Code LPL
• Product: Focus¿ * DAILIES¿ * Toric * One-Day Contact Lenses * CIBA Vision
• Code Information: Lot #6118348 (5 pack), 6110170 (30 pack) and 6110210 (30 pack)
• Recalling Firm/ Manufacturer: Ciba Vision Corporation; 11460 Johns Creek Pkwy; Duluth GA 30097-1518
• For Additional Information Contact: Gina Ingraham; 678-415-4088
• Manufacturer Reason for Recall: Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on/about 07/25/06 to return any of the affected lots found in inventory
• Quantity in Commerce: 86 (approx 1000 lenses) packs total
• Distribution: Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA.
• 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.

• 510(K) Database: 510(K)s with Product Code = LPL and Original Applicant = CIBA VISION CORPORATION