HydroCurve II Bifocal Lens

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

Full name

Hydrocurve

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17752 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S026

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• Are the HydroCurve II Bifocal Lenses designed for continuous wear, or are they meant for daily wear only?

  The HydroCurve II Bifocal Lenses are explicitly designed for daily wear only, as stated in the device description. They are not intended for continuous or extended wear beyond a single day, aligning with standard soft contact lens care protocols.

• How are the HydroCurve II Bifocal Lenses supplied, and are they sterile?

  The lenses are supplied as single-use, non-sterile devices. This means each lens is intended for one-time wear and must be handled according to standard contact lens hygiene practices, including proper cleaning and disinfection if reused (though single-use is recommended).

• What regulatory pathway was followed for approval of the HydroCurve II Bifocal Lenses, and what does this mean for clinicians?

  The HydroCurve II Bifocal Lenses were approved through the FDA Premarket Approval (PMA) pathway, indicated by the PMA number N17752 and the product code LPL. This means the device underwent rigorous clinical evaluation to ensure safety and effectiveness for correcting refractive errors while providing bifocal vision, ensuring clinicians can rely on its validated performance for presbyopia or dual focal range needs.

• Are there multiple sizes or models available for the HydroCurve II Bifocal Lenses, and how would I identify the correct fit?

  While the provided data does not specify exact sizes or models (e.g., base curve, diameter, or power ranges), the HydroCurve II Bifocal Lens is categorized under ‘Lenses, soft contact, daily wear’ with a PMA approval, implying it is available in standard soft contact lens parameters. Clinicians should rely on standard fitting protocols and manufacturer guidelines (e.g., prescription requirements) to determine the appropriate size and model for each patient’s refractive needs.

• How should the HydroCurve II Bifocal Lenses be stored, and are there any specific handling instructions?

  The lenses are non-sterile and supplied for single-use, so storage should follow standard contact lens handling practices to maintain hygiene. They should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Since they are not sterile, they must not be reused without proper cleaning and disinfection, which may void their single-use designation. Always follow the manufacturer’s instructions for optimal storage and handling.