Integrated Orbital Implants Inc: 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.

Recall number

Z-2624-2011

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.

Status

Terminated

Initiated

2011-05-20

Posted

2011-06-22

Terminated

2012-01-11

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.

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K003338"]

PMA numbers

not on file

Product code

hpz

Firm FEI

3009688114

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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