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PCB0000140

by Johnson & Johnson Surgical Vision, Inc.

Ref PCB0000140Model PCB00

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF00003896800030663 Basic UDI-DI D-USMF00003896800030663UDI-DIDate19 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF00003896800030663 UDI-DI Date30 Jun 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tecnis IOL
Generic Name
Posterior-chamber intraocular lens, pseudophakic
Model / Ref / Catalog
PCB00, PCB0000140
Primary DI / UDI-DI
D-USMF00003896800030663 EUDAMED
05050474558144 GUDID
Basic UDI-DI
B-USMF00003896800030663
FDA Product Code
HQL
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
GMDN Term
Posterior-chamber intraocular lens, pseudophakic
Device Class
Class IIb EUDAMED
Class III GUDID
Regulation Number
886.3600
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 13 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF00003896800030663
GUDID
05050474558144
Device ClassEUDAMED
Class IIb
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000038968
Authorised representative
AMO Ireland IE-AR-000013513

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No