FDA.report

REZOOM IOL

Primary DI
05050474520202
Brand
REZOOM IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
NXG1
Catalog number
NXG1BU0170
Device description
NXT GEN ACRY 13.0MM 6OPT MOD C PMMA OPTG
Published
2015-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MFKLENS, MULTIFOCAL INTRAOCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474520202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474520202050504745202025050474520202

GMDN Terms

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

TypeValueUnit
Outer Diameter13Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature045 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags

DUNS number
103021940
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00380658490065Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490072Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490089Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490096Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490102Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490119Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490126Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490133Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490140Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490157Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490164Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490171Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490188Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490195Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490201Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490218Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490225Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490232Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490249Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490256Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490263Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490270Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490287Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490294Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490300Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490317Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490324Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490331Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490348Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490355Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01