FDA.reportPublic FDA data

PREVUE C

Primary DI
10757770563897
Brand
PREVUE C
Company
HOYA MEDICAL SINGAPORE PTE. LTD.
Model
PREVUE (clear), +7.00D
Device description
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
Published
2020-11-10
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770563897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777056389710757770563897

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
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
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
10757770564078PREVUE CPREVUE (clear), +16.00D2020-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658439668ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439675ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439682ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439699ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439705ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439712ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439729ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439736ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439743ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439750ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439767ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439774ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439781ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439798ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439804ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439811ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439828ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439835ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439842ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439859ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439866ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439873ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439880ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439897ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439903ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439910ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439927ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439934ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439941ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439958ClareonAlcon Laboratories, Inc.HQL2026-08-27