Events

Recall of Fresh Look * Radiance¿ * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA.

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
    31864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0847-05
  • Event Initiated Date
    2005-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38638
  • 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 actual power of the lenses may be different from what is indicated on the package labeling.
  • Action
    Consignees were notified via traceable mail on April 21, 2005.

Device

Fresh Look * Radiance¿ * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 ...
  • Model / Serial
    Lot #124637
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Europe
  • Product Description
    Fresh Look * Radiance¿ * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11460 Johns Creek Pkwy, Duluth GA 30097-1518
  • Source
    USFDA