Class 3 Device Recall CIBA Vision contact lens

• Date Initiated by Firm: January 17, 2003
• Date Posted: May 01, 2003
• Recall Status: Terminated on May 01, 2003
• Recall Number: Z-0787-03
• Recall Event ID: 26077
• PMA Number: P830037
• Product Classification: Lenses, Soft Contact, Extended Wear - Product Code LPM
• Product: FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
• Code Information: Lot number 064429, Expiration date, 2006/11
• Recalling Firm/ Manufacturer: Ciba Vision Corporation; 11440 Johns Creek Parkway; Duluth GA 30097
• For Additional Information Contact: Steve Stouphauer; 678-415-3388
• Manufacturer Reason for Recall: FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.
• Quantity in Commerce: 309/six pack cartons
• Distribution: The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.
• 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