Class 2 Device Recall CIBASoft Visitint

• Date Initiated by Firm: April 30, 2007
• Date Posted: May 09, 2007
• Recall Status: Terminated on March 13, 2008
• Recall Number: Z-0793-2007
• Recall Event ID: 37854
• PMA Number: P820086
• Product Classification: Soft Contact Lenses - Product Code LPL
• Product: CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.
• Code Information: Lot #41074100201110
• 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: Base curve of the lenses do not meet specification.
• FDA Determined Cause: Other
• Action: Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
• Quantity in Commerce: 22 lenses
• Distribution: Nationwide.
• 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 = LPL