FDA.reportPublic FDA data

PMMA (P359UV)

Primary DI
10757770097132
Brand
PMMA (P359UV)
Company
Bausch & Lomb Incorporated
Model
P359UV
Catalog number
2R195
Device description
posterior chamber intraocular lens +19.5D
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10757770097132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777009713210757770097132

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
196603781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

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
10757770097149PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17