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AcrySof™ IQ Vivity™ DFT415

by Alcon Laboratories, Inc. 41 variants

Ref DFT415.220

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

CE MDR

Valid until

29 Aug 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 NumberG70 020895 0397 Date11 Jun 2026IssuedStatusActive expires 29 Aug 2028
United StatesGUDID listing GUDID Number00380652422093 UDI-DI Date20 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0397 Active Supplemented

    Technical documentation EU MDR

    Issued
    11 Jun 2026
    Expires
    29 Aug 2028
    Reason
    Add device or group

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
AcrySof IQ Vivity EUDAMED
AcrySof™ IQ Vivity™ GUDID
Generic Name
Posterior-chamber intraocular lens, pseudophakic
Device Name
AcrySof IQ Vivity Toric Extended Vision IOLs
Model / Ref / Catalog
DFT415.220, DFT415
Primary DI / UDI-DI
00380652422093
Basic UDI-DI
038065GMN000134GZ
FDA Product Code
POE
EMDN Code
P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, 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
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DFT415.220
GUDID
DFT415
Device ClassEUDAMED
Class IIb
GUDID
Class III

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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