FDA.report

PURESEE IOL

Primary DI
05050474819863
Brand
PURESEE IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
DET225
Catalog number
DET225U320
Device description
TEC PURESEE TOR II SMPCY 32.0D CYL2.25
Published
2026-03-16
Public version status
New
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
POEExtended depth of focus intraocular lens

Product Code Classifications

CodeDeviceSpecialtyClass
POEExtended Depth Of Focus Intraocular LensOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474819863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474819863050504748198635050474819863

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. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter13Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature5 Degrees Celsius35 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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
05050474806160PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806184PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806191PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806221PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806283PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806290PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806313PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806337PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806382PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806399PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806405PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806436PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806443PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806467PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806474PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806498PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806504PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806528PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806559PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806573PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806580PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806627PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806634PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806665PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806672PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806696PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806702PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806719PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806726PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806733PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16