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AcrySof™ IQ Vivity™ DFT615

by Alcon Laboratories, Inc. 41 variants

Ref DFT615.255

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

Overview

The AcrySof IQ Vivity is a high-performance, sterile posterior-chamber intraocular lens designed for permanent implantation in the eye. This advanced device features a foldable acrylic design with UV and blue light filtering, ensuring optimal visual acuity and comfort. The postoperative care process involves accurate handling and storage of the device to prevent contamination.

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 Number00380652423397 UDI-DI Date30 Jun 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0397 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    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  • Withdrawn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
DFT615.255, DFT615
Primary DI / UDI-DI
00380652423397
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
DFT615.255
GUDID
DFT615
Device ClassEUDAMED
Class IIb
GUDID
Class III

Related devices

Category: Posterior-chamber intraocular lens, pseudophakic

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