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Sensar IOL AAB00

by Johnson & Johnson Surgical Vision, Inc. 49 variants

Ref AAB0000090

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

CE MDR

Valid until

1 Mar 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5050474a000189K Basic UDI-DI 05050474548442UDI-DIDate6 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05050474548442 UDI-DI Date10 Mar 2016ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2252965TD02 Restricted

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Oct 2028
    Reason
    Other
  • 2252965CE02 Expiring Supplemented Expires in 120 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Mar 2027
    Reason
    Other

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Sensar Monofocal 1-Piece IOL EUDAMED
Sensar IOL GUDID
Generic Name
Posterior-chamber intraocular lens, pseudophakic
Device Name
Sensar Spherical Monofocal 1-Piece IOL
Model / Ref / Catalog
AAB0000090, AAB00
Primary DI / UDI-DI
05050474548442
Basic UDI-DI
5050474a000189K
FDA Product Code
HQL
EMDN Code
P030102090101 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, 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
Model / ReferenceEUDAMED
AAB0000090
GUDID
AAB00
Device ClassEUDAMED
Class IIb
GUDID
Class III

Related devices

Category: Posterior-chamber intraocular lens, pseudophakic

Other devices from Johnson & Johnson Surgical Vision, Inc.

See all devices from Johnson & Johnson Surgical Vision, Inc. →

Properties

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

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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