Events

Recall of Device Recall Cornea Power Kit (software)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Optovue 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
    61373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1340-2012
  • Event Initiated Date
    2012-02-21
  • Event Date Posted
    2012-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107932
  • 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
    Tomography, optical coherence - Product Code OBO
  • Reason
    A few doctors in the us were inadvertently sent the cornea power software version kit for international users instead of the domestic version.
  • Action
    Field Correction letters were sent to all doctors affected by the issue on February 23, 2012. The letter identified the affected product and the problem. The letter also stated that customers may continue to use the RTVue until the correction was made. Once the correction has been made, customers are to sign and return the attached acknowledgement form. If customers had questions, they are to contact Optovue at 1-866-344-8948 or via mail at 45531 Northport Loop W, Fremont, CA 94538.

Device

Device Recall Cornea Power Kit (software)
  • Model / Serial
    Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA and WA only
  • Product Description
    RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
  • Manufacturer
    Optovue Inc.

Manufacturer

Optovue Inc.
  • Manufacturer Address
    Optovue Inc., 45531 Northport Loop W, Fremont CA 94538-6417
  • Manufacturer Parent Company (2017)
    Optovue Inc.
  • Source
    USFDA