FDA.reportPublic FDA data

Ophthalmic Conformer

Primary DI
G542V26280
Brand
Ophthalmic Conformer
Company
THE EYE CONCERN, INC.
Model
V2628
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HQNConformer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQNConformer, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G542V26280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic conformerAn 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.

Regulatory Flags#

DUNS number
199692406
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G542V26230Artificial EyeV26232024-01-10
G542V26270Scleral ShellV26272024-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
CONFV2628Soper Brothers CustomSoper Brothers, IncorporatedHQN2026-03-03
00860015162823Dallas Eye ProstheticsDallas Eye ProstheticsHQN2025-12-23
G568V2628Ophthalmic ConformerTHOMPSON OCULAR PROSTHETICS, INC.HQN2025-03-10
B796V2628Ophthalmic ConformerMIDWEST EYE LABORATORIES, INC.HQN2024-03-28
G519V2628Ophthalmic ConformerMidwest Eye Laboratories Sioux Falls, LLCHQN2024-03-10
G290V2628Ophthalmic ConformerMidwest Eye Laboratories Woodbury, LLCHQN2024-02-20
G521V2628Ophthalmic ConformerLegrand AssociatesHQN2023-10-18
00854428006195Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006201Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006218Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006348Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006355Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006362Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
10697660001002Bilateral Conformers 22 Extra-SmallOculo-Plastik IncHQN2021-06-08
13700773724908SYMBLEPHARON RING 25 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724915SYMBLEPHARON RING 20 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724922SYMBLEPHARON RING 22 MMFCI S A S FCI 20 22HQN2021-05-30
03760087122589SILICONE CONFORMER (FLEXIBLE)FCI S A S FCI 20 22HQN2021-05-30
B863E661090V2628Ophthalmic ConformerTEXAS EYE PROSTHETICS LLCHQN2020-04-14
03760087122732Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122749Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122756Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
10697660002344Symblepharon Ring Conformer SmallOculo-Plastik IncHQN2019-10-23
10697660002368Symblepharon Ring Conformer MediumOculo-Plastik IncHQN2019-10-23
10697660002382Symblepharon Ring Conformer LargeOculo-Plastik IncHQN2019-10-23
10697660001132Bilateral Conformer 18 SmallOculo-Plastik IncHQN2019-10-21
10697660001194Bilateral Conformer 16 RegularOculo-Plastik IncHQN2019-10-21
10697660001095Bilateral Conformer 18/20 SmallOculo-Plastik IncHQN2019-10-21
10697660001118Bilateral Conformer 18/20 RegularOculo-Plastik IncHQN2019-10-21
10697660001156Bilateral Conformer 18 RegularOculo-Plastik IncHQN2019-10-21