Class 2 Device Recall Coated BioEye Orbital Implant w/Conformer.

• Date Initiated by Firm: May 20, 2011
• Date Posted: June 22, 2011
• Recall Status: Terminated on January 11, 2012
• Recall Number: Z-2624-2011
• Recall Event ID: 58877
• 510(K)Number: K003338
• Product Classification: Implant, eye sphere - Product Code hpz
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Integrated Orbital Implants Inc; 12625 High Bluff Dr Ste 314; San Diego CA 92130-2054
• For Additional Information Contact: 858-259-4355
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 4237
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = hpz and Original Applicant = INTEGRATED ORBITAL IMPLANTS, INC.