Events

Recall of Device Recall BioEye

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integrated Orbital Implants 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
    36298
  • Event Risk Class
    Class 3
  • Event Number
    Z-0012-2007
  • Event Initiated Date
    2006-02-27
  • Event Date Posted
    2006-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48367
  • 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
    orbital implant - Product Code HPZ
  • Reason
    The end label on the outer box was mislabeled on 9 of a 10 unit lot. the end label says ''22 mm'' and the implants are actually ''20 mm''. the main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
  • Action
    The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.

Device

Device Recall BioEye
  • Model / Serial
    Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Internationally to Finland & France
  • Product Description
    Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Manufacturer Address
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
  • Source
    USFDA