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U.S. Department of Health and Human Services

Class 2 Device Recall Glitter Eyes

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  Class 2 Device Recall Glitter Eyes see related information
Date Initiated by Firm March 17, 2003
Date Posted April 01, 2003
Recall Status1 Terminated 3 on April 07, 2004
Recall Number Z-0703-03
Recall Event ID 25796
510(K)Number K003071  
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
Code Information Green, PID Lot#NA, Button Lot#22940-32, Blue, PID Lot#40523337, Button Lot#22940-32, Bronze, PID Lot#40538359, Button Lot#22940-32, Violet, PID Lot#40522198, Button Lot #22940-32, Green, PID Lot#40581596, Button Lot#22985-95, Blue PID Lot 40550786, Button Lot#22620-19, Blue PID Lot#40505677, Button Lot#22620-20, Bronze PID Lot#40540880, Button Lot#22620-19, Violet, PID Lot#40543810, Button Lot#22620-19.
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		 The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
FDA Determined
Cause 2		 Other
Action The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.
Quantity in Commerce 29,821 units
Distribution Nationwide, Canada and Puerto Rico.
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
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