Events

Recall of Device Recall Circle Lens, Europa, Pacifica, Gothika and Water Color.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hebron International, 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
    35597
  • Event Risk Class
    Class 2
  • Event Number
    Z-1257-06
  • Event Initiated Date
    2006-05-10
  • Event Date Posted
    2006-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46446
  • 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
    Soft Contact Lens - Product Code LPL
  • Reason
    Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
  • Action
    Consignees were notified by certified mail on 05/22/2006.

Device

Device Recall Circle Lens, Europa, Pacifica, Gothika and Water Color.
  • Model / Serial
    All lots
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.
  • Manufacturer
    Hebron International, Inc.

Manufacturer

Hebron International, Inc.
  • Manufacturer Address
    Hebron International, Inc., 5265 Buford Hwy., Atlanta GA 30340
  • Source
    USFDA