Bio-Eye®

Basic Information

• Brand Name: Bio-Eye®
• Primary DI: 00854066006113
• Version / Model: I0022P
• Company Name: INTEGRATED ORBITAL IMPLANTS INC
• Labeler DUNS: 859186348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-01
• Public Version: 5
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: c1e04e02-4da4-40cf-8a3c-f0acd6a4b095

Device Description

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQN	Conformer, Ophthalmic	Ophthalmic	886.3130	2
MTZ	Wrap, Implant, Orbital	Ophthalmic	886.3320	2
HPZ	Implant, Eye Sphere	Ophthalmic	886.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46902	Orbital sphere implant	An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.	Yes	Active
44477	Orbital sphere implant wrap, non-biological	An implantable ocular device designed as an external cover (a wrap) for an orbital implant used in enucleation surgery, and to protect the surrounding orbital tissue from the surface of the implant. It is typically made of materials available in sheet form [e.g., polylactide (PLA), hydroxyapatite] that can be cut to the desired shape and size. It may be made malleable by submersion in hot water, after which it can be formed to any three-dimensional (3-D) anatomical orientation. It will typically contain pores that allow for natural vascular tissue ingrowth.	Yes	Active
16065	Ophthalmic conformer	An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854066006113	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003338	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	22	Millimeter