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Class 2 Device Recall Glitter Eyes |
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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
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Product Classification |
Lenses, Soft Contact, Daily Wear - Product Code LPL
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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
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For Additional Information Contact |
Steve Strouphauer 678-415-3388
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Manufacturer Reason for Recall |
The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LPL and Original Applicant = CIBA VISION CORPORATION
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