Events

Recall of Device Recall Private Eyes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Contact Lens Store, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1313-04
  • Event Initiated Date
    2004-06-07
  • Event Date Posted
    2004-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33462
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Reason
    The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
  • Action
    Consignees were first contacted by telephone with a f/u letter sent 6/7/2004

Device

Device Recall Private Eyes
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, TX, WA.
  • Product Description
    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..
  • Manufacturer
    The Contact Lens Store, Inc.

Manufacturer

The Contact Lens Store, Inc.
  • Manufacturer Address
    The Contact Lens Store, Inc., 638 Church Street, Marietta GA 30060
  • Source
    USFDA