Meso (Cellulose Acetate Butyrate) Hard Contact Lens

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Lens, contact (other material) - daily

PMA Number

N17878 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• What is the primary material used in the MESO Hard Contact Lens, and how does it differ from other contact lens materials?

  The MESO Hard Contact Lens is made from cellulose acetate butyrate, a rigid gas-permeable (RGP) material designed to correct refractive errors while allowing oxygen to reach the cornea. Unlike softer hydrogel lenses, this material provides a firmer fit, which can improve stability and vision clarity for certain patients, particularly those with astigmatism or corneal irregularities. The oxygen permeability helps maintain corneal health during daily wear.

• Is the MESO Hard Contact Lens intended for daily or extended wear, and what are the key considerations for use?

  The MESO Hard Contact Lens is explicitly designed for daily wear only, meaning it is not approved for overnight or extended use. It requires professional fitting and maintenance by an eye care practitioner to ensure proper placement, hygiene, and corneal health. Since it is a single-use, sterile product, each lens must be discarded after removal, and replacement lenses must follow strict sterile handling protocols to prevent infection or irritation.

• How is the MESO Hard Contact Lens supplied, and what storage instructions should be followed?

  The MESO Hard Contact Lens is supplied as a single-use, sterile product in individual packaging. Storage must comply with standard sterile contact lens protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediate use, and any unused lenses must be discarded to maintain sterility and safety. Always follow the eye care practitioner’s instructions for storage and handling.

• What regulatory pathway does the MESO Hard Contact Lens follow, and what does this mean for clinicians or buyers?

  The MESO Hard Contact Lens follows the FDA Premarket Approval (PMA) pathway, indicated by PMA number N17878 and product code HQD. This means the device has undergone rigorous clinical evaluation and approval by the FDA to ensure safety and effectiveness for its intended use. Clinicians or buyers should confirm that their practice adheres to FDA guidelines for RGP lens fitting, maintenance, and patient follow-up, as required by the approval.

• Are there different sizes or models available for the MESO Hard Contact Lens, and how are they determined?

  While the provided data does not list specific base curve, diameter, or power variations, the MESO Hard Contact Lens is designed to accommodate various refractive corrections through custom fitting by an eye care practitioner. Sizes and models are determined based on the patient’s corneal curvature, prescription, and ocular health. The practitioner selects the appropriate lens parameters to ensure comfort, stability, and optimal vision correction. Always consult with an eye care professional to determine the correct fit.