Skip to content

Clareon, Panoptix

by Alcon Laboratories, Inc. United States EUDAMED

Ref CCWTT0-190

EMDN P030102100201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000148HC Basic UDI-DIDate3 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0419 Withdrawn

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Jun 2026
    Expires
    26 Jun 2030
    Reason
    Transferred to other nb

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Clareon PanOptix Trifocal UV Absorbing IOL
Model / Reference
CCWTT0-190
Primary DI / UDI-DI
00380658481261
Basic UDI-DI
038065GMN000148HC
EMDN Code
P030102100201 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Animal Tissues
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00380658481261|038065GMN000148HC 61 fields · synced 24 Oct 2026