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PRECISION1

by Alcon Laboratories, Inc.

Ref many

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K182902; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182902↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000293HN Basic UDI-DI Date8 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK182902 Date11 Dec 2018IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0326-2026 FDA Class II initiated 30 Sep 2025 on shared 510(k) K182902

    Potential for a weak seal in some units resulting in compromise in sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Alcon Vision Correction Contact Lenses
Model / Reference
many
Primary DI / UDI-DI
030065M0002378, 030065M0002276, 030065M000247A
Basic UDI-DI
038065GMN000293HN
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU market of registration
Germany

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

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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