Events

Recall of Device Recall Coated BioEye Orbital Implant w/Conformer.

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
    58877
  • Event Risk Class
    Class 2
  • Event Number
    Z-2624-2011
  • Event Initiated Date
    2011-05-20
  • Event Date Posted
    2011-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100459
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Implant, eye sphere - Product Code hpz
  • Reason
    The recall was initiated because integrated orbital implants has confirmed certain lots of the coated bio-eye were manufactured without expiration dating visible on the packaging. all unlabeled product is currently beyond its expiration date.
  • Action
    Integrated Orbital Implants Inc initiated a recall communication on 5/20/2011 with Integrated Orbital Implants (IOI) forwarding a Urgent Safety Notification letter to all their customers who had purchased the Coated Bio-Eye implants. The letter asked the customers to look for evidence of a printed expiration date on Coated Bio-eye package. If any Coated BioEye packages were not labeled with an expiration date the letter instructed customers to immediately sequester the products and not to use the products in surgery and contact IOI by telephone at (858) 6779990 or 1 (800) 4246537 to request an RMA number and shipping instructions. Also stated in the letter, IOI will replace Coated BioEye implants without expiration dates free of charge upon receipt of the implants labeled without expiration dates.

Device

Device Recall Coated BioEye Orbital Implant w/Conformer.
  • Model / Serial
    Lot/Unit Codes: 32764, 35906, 35907, 35908, 36307, 36308, 36309, 36315, 36316, 36364, 36430, 36431, 36469, 36470, 36471, 36476, 49216, 54304, 54569, 63449, 63450, 63710, 63803.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore.
  • Product Description
    Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. || Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. || Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. || Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in || implant insertion and provides a means of securing muscles to the implant. || The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.
  • 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