FDA.reportPublic FDA data

DGR

Primary DI
M454PS60C2UVP0901
Brand
DGR
Company
EYEKON MEDICAL, INC.
Model
PS60C-2UV-09.0
Device description
POSTERIOR CHAMBER INTRAOCULAR LENS
Published
2015-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880072000MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOLEyekon Medical, Inc.1989-09-22HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M454PS60C2UVP0901PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803926252
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
U400DP3001ISOTECHNICSU400D-30.02015-09-18
M454AR120P0401ACURUSAR120-04.02015-09-18
M454AR120P0451ACURUSAR120-04.52015-09-18
M454AR120P0501ACURUSAR120-05.02015-09-18
M454AR120P0551ACURUSAR120-05.52015-09-18
M454AR120P0601ACURUSAR120-06.02015-09-18
M454AR120P0651ACURUSAR120-06.52015-09-18
M454AR120P0701ACURUSAR120-07.02015-09-18
M454AR120P0751ACURUSAR120-07.52015-09-18
M454AR120P0801ACURUSAR120-08.02015-09-18
M454AR120P0851ACURUSAR120-08.52015-09-18
M454AR120P0901ACURUSAR120-09.02015-09-18
M454AR120P0951ACURUSAR120-09.52015-09-18
M454AR120P1001ACURUSAR120-10.02015-09-18
M454AR120P1051ACURUSAR120-10.52015-09-18
M454AR120P1101ACURUSAR120-11.02015-09-18
M454AR120P1151ACURUSAR120-11.52015-09-18
M454AR120P1201ACURUSAR120-12.02015-09-18
M454AR120P1251ACURUSAR120-12.52015-09-18
M454AR120P1301ACURUSAR120-13.02015-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770096746PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096760PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096784PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096807PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096821PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096845PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096869PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096883PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096906PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096920PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096944PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096951PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096968PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096975PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096982PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096999PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097002PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097019PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097026PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097033PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097040PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097057PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097064PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097071PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097088PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097095PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097101PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097118PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097125PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097132PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17