Events

Recall of Device Recall Glitter Eyes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ciba Vision Corporation.

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
    25796
  • Event Risk Class
    Class 2
  • Event Number
    Z-0703-03
  • Event Initiated Date
    2003-03-17
  • Event Date Posted
    2003-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26487
  • 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 lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
  • 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.

Device

Device Recall Glitter Eyes
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Puerto Rico.
  • Product Description
    Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11440 Johns Creek Parkway, Duluth GA 30097
  • Source
    USFDA