Metrosoft Deltafilcona Hydrophilic Contact Lenses

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

P800013 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Metro 55g Toric & Spherical

  Class II

  FDA 510(k) K953199 Active Cleared 11 Dec 1995

• Metrosoft II, Metrosoft Toric, Metrolite, Metrotint, Satureyes, Satureyes Toric, Satureyes Lite, Satureyes Lite Toric

  Class II

  FDA 510(k) K983021 Active Cleared 13 Nov 1998

• Metro 55 (Methafilcon a)

  Class II

  FDA PMA P830077 Active Approved 21 Feb 1989

• Metrosoft II (Polymacon) Hydrophilic Contact Lenses

  Class II

  FDA PMA P820026 Active Approved 25 Oct 1985

• Are these contact lenses intended for overnight wear, or are they strictly for daily use only?

  These lenses are explicitly designed for daily wear only, as stated in the description. They are not approved or intended for extended or overnight use, which would require a different classification and regulatory pathway.

• How should these contact lenses be stored, and do they come pre-sterilized?

  The lenses are supplied as non-sterile and must be sterilized by the user before use, following the manufacturer’s guidelines. Storage should adhere to Metrosoft, Inc.’s instructions to maintain safety and efficacy, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data.

• Can these lenses be reused, or are they single-use only?

  These lenses are single-use only, as explicitly stated in the description. They are not designed for reuse, which aligns with their classification as daily-wear contact lenses.

• What regulatory pathway was followed for approval of these lenses, and how does that affect their use?

  These lenses were approved through the FDA Premarket Approval (PMA) process, indicated by the `FDA_PMA` authorization and the PMA number (P800013). This means they underwent rigorous clinical evaluation to ensure safety and effectiveness for correcting refractive errors and improving visual acuity, as described. The PMA route is typically reserved for higher-risk devices, ensuring compliance with stringent standards.

• What range of prescriptions or sizes are available for these contact lenses?

  The lenses are available in multiple sizes and prescriptions, as evidenced by the extensive list of registration numbers (e.g., 3015533540, 3012546757, etc.). These numbers correspond to specific product codes and variations, but the exact diopter ranges or base curve sizes are not detailed in the provided data. For precise prescription options, refer to Metrosoft, Inc.’s product catalog or technical documentation.