FDA.reportPublic FDA data

Intacs for Keratoconus, Symmetric 0.350 mm

Primary DI
00850048576131
Brand
Intacs for Keratoconus, Symmetric 0.350 mm
Company
ADDITION TECHNOLOGY, INC.
Model
ICI-350-150
Catalog number
11600-350-150
Device description
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQEImplant, Corneal, Refractive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQEImplant, Corneal, RefractiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H040002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H040002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048576131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048576131008500485761318500485761310850048576131

GMDN Terms#

Term, Definition table
TermDefinition
Intracorneal ring segmentAn implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. It is typically a plastic arc, of about 150 degrees and provided in pairs, inserted into the cornea via an intrastromal channel created with a diamond knife or laser, and that can be implanted away from the radial incision to minimize complications. It is typically available in sizes from 0.25 to 0.35 mm. The device is intended to correct mild and moderate myopia and to treat patients with irregular astigmatism as a result of keratoconus, especially those who can no longer benefit from contact lenses or spectacles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118496814
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048576001Intacs Corneal Separator, CW, 0.9mmKV10730-12023-06-13
00850048576018Intacs Corneal Separator, CCW, 0.9mmKV10730-22023-06-13
00850048576025Intacs Inspection GaugeKV107322023-06-13
00850048576032Intacs Procedure MarkerKV107332023-06-13
00850048576049Intacs ForcepsKV104452023-06-13
00850048576056Intacs Vacuum Centering GuideKV10478-22023-06-13
00850048576063Intacs Pocketing HookKV106062023-06-13
00850048576070Intacs Symmetric GlideKV11602023-06-13
00850048576100Intacs for Keratoconus, Symmetric 0.210 mmICI-210-15011600-210-1502023-06-13
00850048576117Intacs for Keratoconus, Symmetric 0.250 mmICI-250-15011600-250-1502023-06-13
00850048576124Intacs for Keratoconus, Symmetric 0.300 mmICI-300-15011600-300-1502023-06-13
00850048576148Intacs for Keratoconus, Symmetric 0.400 mmICI-400-15011600-400-1502023-06-13
00850048576155Intacs for Keratoconus, Symmetric 0.450 mmICI-450-15011600-450-1502023-06-13
00850048576162Intacs for Keratoconus, Asymmetric 0.210/0.350 mmICIA-210/350-15011400-210/350-1502023-06-13
00850048576179Intacs for Keratoconus, Asymmetric 0.210/0.400 mmICIA-210/400-15011400-210/400-1502023-06-13
00850048576186Intacs for Keratoconus, Asymmetric 0.210/0.450 mmICIA-210/450-15011400-210/450-1502023-06-13
00850048576193Intacs for Myopia, Symmetric 0.250 mmICI-250-15011700-250-1502023-06-13
00850048576209Intacs for Myopia, Symmetric 0.300 mmICI-300-15011700-300-1502023-06-13
00850048576216Intacs for Myopia, Symmetric 0.350 mmICI-350-15011700-350-1502023-06-13
00866304000142Intacs Sterile Vacuum Tubing7K60002023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048576100Intacs for Keratoconus, Symmetric 0.210 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576117Intacs for Keratoconus, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576124Intacs for Keratoconus, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576148Intacs for Keratoconus, Symmetric 0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576155Intacs for Keratoconus, Symmetric 0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576162Intacs for Keratoconus, Asymmetric 0.210/0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576179Intacs for Keratoconus, Asymmetric 0.210/0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576186Intacs for Keratoconus, Asymmetric 0.210/0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576193Intacs for Myopia, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576209Intacs for Myopia, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576216Intacs for Myopia, Symmetric 0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00813359020052KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-13
00813359020045KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-05
10850394006013Raindrop Near Vision InlayREVISION OPTICS, INC.LQE2016-08-19
10850394006051Inlay Inserter Chuck HandleREVISION OPTICS, INC.LQE2016-08-19
00866304000104Intacs Corneal ImplantsADDITION TECHNOLOGY, INC.LQE2015-06-30
00813359020007KAMRA inlayBausch & Lomb IncorporatedLQE2015-04-29