| Class 2 Device Recall Private Eyes | |
Date Initiated by Firm | June 07, 2004 |
Date Posted | August 05, 2004 |
Recall Status1 |
Terminated 3 on September 16, 2004 |
Recall Number | Z-1313-04 |
Recall Event ID |
29281 |
Product Classification |
Lenses, Soft Contact, Daily Wear - Product Code LPL
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Product | Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire.. |
Code Information |
Unknown. The firm failed to establish a lot numbering system for the theatrical contact lenses. The majority of the vials in stock at the firm have lot number BB43. |
Recalling Firm/ Manufacturer |
The Contact Lens Store, Inc. 638 Church Street Marietta GA 30060
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For Additional Information Contact | James R. Childress 770-514-7272 |
Manufacturer Reason for Recall | The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling. |
FDA Determined Cause 2 | Other |
Action | Consignees were first contacted by telephone with a f/u letter sent 6/7/2004 |
Quantity in Commerce | 618 vials |
Distribution | MA, TX, WA. |
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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