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U.S. Department of Health and Human Services

Class 2 Device Recall Private Eyes

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  Class 2 Device Recall Private Eyes see related information
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
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
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
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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