Z-2624-2011

Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere...

Name: Z-2624-2011 Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere...
Creator: Integrated Orbital Implants Inc
Published: 2011-05-20
License: https://open.fda.gov/license/

Integrated Orbital Implants Inc / initiated 2011-05-20 / Terminated / root cause: packaging

FDA source

Integrated Orbital Implants Inc began a recall of Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C... on 2011-05-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2624-2011
Status: Terminated
Initiated: 2011-05-20
Posted: 2011-06-22
Terminated: 2012-01-11
Recalling firm: Integrated Orbital Implants Inc
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.
Product code: hpz
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.
Root cause tag: packaging
FDA root 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.
Product codes and lots: 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 code hpz

K003338Class IIBio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. / cleared 2001-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)