FDA.reportPublic FDA data

ISOTECHNICS

Primary DI
U400DP3001
Brand
ISOTECHNICS
Company
EYEKON MEDICAL, INC.
Model
U400D-30.0
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
U400DP3001PrimaryHIBCC0

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.

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
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
M454AR120P1351ACURUSAR120-13.52015-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414846625238FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625245FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625252FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625269FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625276FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625283FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625290FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625306FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
10757770606495enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606501enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606518enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606525enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606532enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606549enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606563enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606570enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606587enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606594enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606600enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606617enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606624enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606631enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606648enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606655enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606662enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606679enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606686enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606693enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606709enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606716enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05