Class 2 Device Recall HYPA C7

• Date Initiated by Firm: November 13, 2002
• Date Posted: December 31, 2002
• Recall Status: Terminated on January 04, 2005
• Recall Number: Z-0400-03
• Recall Event ID: 25016
• Product Classification: Lenses, Soft Contact, Daily Wear - Product Code LPL
• Product: Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)
• Code Information: Lot numbers BB63 and BB73 on containers that hold lenses. Lot number 123410 is on inner box that holds 3 pairs of lenses.
• Recalling Firm/ Manufacturer: My Cosmetics Inc; 9950 Bell Ranch Dr Ste 106; Santa Fe Springs CA 906706159
• For Additional Information Contact: Harry Han; 562-903-7740
• Manufacturer Reason for Recall: Products are being distributed from importer directly to retail outlets labeled 'for cosmetic use only'
• FDA Determined Cause: Other
• Action: Firm began to telephone contact recall customers on 11/20/2002. Letters will also be sent requesting return of any remaining stock.
• Distribution: Nationwide. States of AL, AR, CA, DE, FL, GA, KY, LA, MD, MS, MO, NV, NY, NC, NE, OK, TN, TX, 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.