Hydro Marc Lenses (Hydrophilic)

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

N18033 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S014

• Vistakon (Lenefilcon a)Contact Lens Clear and Visibility Tint with UV Blocker

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  FDA 510(k) K983912 Active Cleared 26 Jan 1999

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• Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear

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  FDA 510(k) K991134 Active Cleared 6 May 1999

• Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker

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  FDA 510(k) K962804 Active Cleared 1 Oct 1996

• Vistakon Multifocal (Etafilcon a) Contact Lens

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  FDA 510(k) K953804 Active Cleared 26 Sep 1995

• Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear

  Class II

  FDA 510(k) K991163 Active Cleared 8 Jun 1999

See all devices from Vistakon, Johnson & Johnson Vision Products, Inc. →

• Are the Hydro Marc Lenses reusable or designed for single-use only?

  The Hydro Marc Lenses (Hydrophilic) are explicitly designed as single-use or disposable contact lenses. They are not intended for reuse, aligning with their classification as daily-wear soft contact lenses.

• What regulatory pathway was followed for approval of these lenses?

  The Hydro Marc Lenses (Hydrophilic) were authorized through the FDA Premarket Approval (PMA) process, with approval granted under PMA number N18033. This pathway is typically reserved for higher-risk medical devices, including certain contact lenses.

• Are there multiple variants of these lenses, and how can I verify compatibility?

  Yes, multiple variants of the Hydro Marc Lenses exist, each associated with distinct registration numbers and FEI numbers (e.g., 3015533540, 3012546757). Compatibility depends on the specific prescription and lens parameters (e.g., curvature, diameter). Always cross-reference the registration number or FEI number with your supplier or prescription to ensure the correct variant is ordered.

• What is the intended clinical use for these lenses, and who should prescribe them?

  These lenses are intended for ophthalmic use to correct refractive errors or improve vision by resting directly on the cornea. They are designed for daily wear and should be prescribed and fitted by trained eye care professionals in clinical settings. The advisory committee classification (Ophthalmic) and product code (LPL) confirm their role in vision correction.