FDA.reportPublic FDA data

Clarisert™

Primary DI
04547480600031
Brand
Clarisert™
Company
HOYA MEDICAL SINGAPORE PTE. LTD.
Model
CLSRT (clear), + 7.00 D
Device description
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
Published
2017-05-19
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
P080004016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080004016HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENSHoya Surgical Optics, Inc.2008-09-26HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547480600031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547480600031045474806000314547480600031

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
894831895
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770563873PREVUE CPREVUE (clear), +6.00D2020-11-10
10757770563880PREVUE CPREVUE (clear), +6.50D2020-11-10
10757770563897PREVUE CPREVUE (clear), +7.00D2020-11-10
10757770563903PREVUE CPREVUE (clear), +7.50D2020-11-10
10757770563910PREVUE CPREVUE (clear), +8.00D2020-11-10
10757770563927PREVUE CPREVUE (clear), +8.50D2020-11-10
10757770563934PREVUE CPREVUE (clear), +9.00D2020-11-10
10757770563941PREVUE CPREVUE (clear), +9.50D2020-11-10
10757770563958PREVUE CPREVUE (clear), +10.00D2020-11-10
10757770563965PREVUE CPREVUE (clear), +10.50D2020-11-10
10757770563972PREVUE CPREVUE (clear), +11.00D2020-11-10
10757770563989PREVUE CPREVUE (clear), +11.50D2020-11-10
10757770563996PREVUE CPREVUE (clear), +12.00D2020-11-10
10757770564009PREVUE CPREVUE (clear), +12.50D2020-11-10
10757770564016PREVUE CPREVUE (clear), +13.00D2020-11-10
10757770564023PREVUE CPREVUE (clear), +13.50D2020-11-10
10757770564030PREVUE CPREVUE (clear), +14.00D2020-11-10
10757770564047PREVUE CPREVUE (clear), +14.50D2020-11-10
10757770564054PREVUE CPREVUE (clear), +15.00D2020-11-10
10757770564061PREVUE CPREVUE (clear), +15.50D2020-11-10

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