Events

Recall of Device Recall MAGNIVISION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Magnivision, 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
    26331
  • Event Risk Class
    Class 2
  • Event Number
    Z-0541-04
  • Event Initiated Date
    2003-05-02
  • Event Date Posted
    2004-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27521
  • 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
    Frame, Spectacle - Product Code HQZ
  • Reason
    Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.
  • Action
    The firm sent an e-mail dated 4/16/03 to their only direct wholesaler telling them to hold the product and followed up with a phone call infomring them of the retagging on 5/2/03 and a sufficient quantify of tags to relabel product at the retail level. Also they visited the wholesaler and retagged in house stock with the smaller tag.

Device

Device Recall MAGNIVISION
  • Model / Serial
    Product is not coded.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to a a wholesaler in Florida.
  • Product Description
    Product is Magnivision UltraLights reading glasses which have the dioptic power on the label and ''MAGNIVISION AN AMERICAN GREETINGS COMPANY Miramar, FL 33025''
  • Manufacturer
    Magnivision, Inc.

Manufacturer

Magnivision, Inc.
  • Manufacturer Address
    Magnivision, Inc., 3700 Commerce Pkwy., Miramar FL 33025
  • Source
    USFDA