Company: The Contact Lens Store, Inc.
Date of Enforcement Report: 9/1/04
Class: II
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, 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. Recall # Z-1313-04.
REASON
The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
CODE
The majority of the vials in stock at the firm have lot number BB43 Expiration Date 08/06.
RECALLING FIRM/MANUFACTURER
The Contact Lens Store, Inc., Marietta, GA, by telephone and letter on June 7, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
618 vials.
DISTRIBUTION
MA, TX, WA.
