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Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

by Sauflon Pharmaceuticals, Ltd.

510(k) K130331

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130331 Date26 Jul 2013ClearedStatusActive

Recalls

17 recalls · 1 ongoing · FDA

    • Ongoing Z-3248-2026 FDA Class II initiated 12 Aug 2026

    A small number of lenses within the affected lot are of the incorrect power.

  • 12 recalls, same reason

    • Terminated Z-2143-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2154-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2145-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2147-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2150-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2153-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2149-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2151-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2144-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2146-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2152-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331
    • Terminated Z-2148-2021 FDA Class II initiated 19 May 2021 on shared 510(k) K130331

    Misaligned placement of an axis mark can cause the patient to experience blurred vision

  • 4 recalls, same reason

    • Terminated Z-1515-2018 FDA Class III initiated 21 Feb 2018
    • Terminated Z-1517-2018 FDA Class III initiated 21 Feb 2018
    • Terminated Z-1518-2018 FDA Class III initiated 21 Feb 2018
    • Terminated Z-1516-2018 FDA Class III initiated 21 Feb 2018

    The secondary packaging is labeled with an incorrect expiration date.

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MVN
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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