FDA.reportPublic FDA data

Orbital sphere implant

Primary DI
03760087123074
Brand
Orbital sphere implant
Company
FCI S A S FCI 20 22
Model
MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (20 mm)
Catalog number
S6.5320U
Device description
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.
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPZImplant, Eye Sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760087123074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087123074037600871230743760087123074

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implantAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-932-4202orders@fci-ophthalmics.com

Regulatory Flags#

DUNS number
763408366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602026-02-17
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602021-05-30
23700773707472MACULORHEXIS FORCEPS 27 G S9.6012.272021-05-30
23700773707489END GRASPING FORCEPS 27 G S9.6013.272021-05-30
23700773707496TANO FORCEPS 27 G S9.6017.272021-05-30
23700773707502pince super grip 23GS9.6018.232021-05-30
23700773707519pince super grip 25GS9.6018.252021-05-30
23700773707526pince super grip 27GS9.6018.272021-05-30
23700773721041TANO POLISHER,20G S9.6016.202021-05-29
23700773721058TANO POLISHER,23G S9.6016.232021-05-29
23700773721065TANO POLISHER,25G S9.6016.252021-05-29
23700773721225DISPOSABLE TANO FORCEPS 23GS9.6017.232021-05-30
23700773721232DISPOSABLE TANO FORCEPS 25GS9.6017.252021-05-30
23700773721249DISPOSABLE SERRATED FORCEPS 23GS9.6011.232021-05-30
23700773721256DISPOSABLE SERRATED FORCEPS 25GS9.6011.252021-05-30
23700773721263DISPOSABLE MACULORHEXIS FORCEPS, 23GS9.6012.232021-05-30
23700773721270DISPOSABLE MACULORHEXIS FORCEPS, 25GS9.6012.252021-05-30
23700773721287DISPOSABLE END-GRASPING FORCEPS, 23GS9.6013.232021-05-30
23700773721294DISPOSABLE END-GRASPING FORCEPS, 25GS9.6013.252021-05-30
23700773721324DISPOSABLE VERTICAL SCISSORS, 23GS9.6015.232021-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
13700773724397EZYPOR® Ø 18 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724403EZYPOR® Ø 20 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724410EZYPOR® Ø 22 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728081EZYPOR® Ø 16 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728852EZYPOR® Ø 12 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728890EZYPOR® Ø 14 mm FCI S A S FCI 20 22HPZ2024-06-21
B09114150010mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114151012mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114152014mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114153016mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114154018mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114155020mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114156022mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
03760087122435Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122442Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122459Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122466Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122473Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122480Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122510Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122527Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122916Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122923Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122930Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122954Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122961Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122985Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087123067Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06