Class 3 Device Recall Quick Care Starting Solution

• Date Initiated by Firm: August 13, 2003
• Date Posted: September 13, 2003
• Recall Status: Terminated on January 28, 2005
• Recall Number: Z-1234-03
• Recall Event ID: 26932
• PMA Number: P900029
• Product Classification: Accessories, Soft Lens Products - Product Code LPN
• Product: Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.
• Code Information: Lot No. 1278080, exp. date 5/2004
• Recalling Firm/ Manufacturer: Ciba Vision Corporation; 11440 Johns Creek Parkway; Duluth GA 30097
• For Additional Information Contact: Steve Strouphauer; 678-415-3388
• Manufacturer Reason for Recall: Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.
• FDA Determined Cause: Other
• Action: The consignees were notified of the recall by letter on August 13, 2003 asking for return of the product.
• Quantity in Commerce: 2,136 units
• Distribution: CA, CT, FL, GA, IA, KS, MI, MN, OH, 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 = LPN