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AcrySof

by Alcon Laboratories, Inc. United States EUDAMED

Ref DFT015-260

EMDN P030102100201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000133GX Basic UDI-DIDate21 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0397 Supplemented

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Jun 2026
    Expires
    29 Aug 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Device Name
AcrySof IQ Vivity Extended Vision IOL
Model / Reference
DFT015-260
Primary DI / UDI-DI
00380658420505
Basic UDI-DI
038065GMN000133GX
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
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 00380658420505|038065GMN000133GX 61 fields · synced 24 Oct 2026