Events

Recall of Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and 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
    56329
  • Event Risk Class
    Class 3
  • Event Number
    Z-2292-2010
  • Event Initiated Date
    2010-06-07
  • Event Date Posted
    2010-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93240
  • 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
    Implant, Eye Sphere - Product Code HPZ
  • Reason
    Integrated orbital implants, inc. has initiated a recall of it's sterile bio-eye hydroxyapatite orbital implant and conformer due to a labeling issue in which the expiration date of the product was omitted.
  • Action
    Customers were contacted by telephone and email

Device

Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer
  • Model / Serial
    Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
  • Product Description
    Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Manufacturer Address
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 300, San Diego CA 92130-2054
  • Manufacturer Parent Company (2017)
    Integrated Orbital Implants Inc
  • Source
    USFDA