OP-3 RGP Contact Lens

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

Full name

Op-3 (Tm) Rgp Contact Lens

Generic Name

Lens, contact (other material) - daily

PMA Number

P920045 ↗

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)

• Op-2 (Lotifocon B) & Op-6 (Lotifocon C)

  Class II

  FDA 510(k) K952260 Active Cleared 3 Jan 1996

• What types of vision correction does the OP-3™ RGP Contact Lens support, and how is it different from other daily-wear contact lenses?

  The OP-3™ RGP Contact Lens is specifically designed for corneal refractive correction, meaning it reshapes the cornea to improve vision clarity for conditions like myopia (nearsightedness) or astigmatism. Unlike soft contact lenses, it is made from a rigid gas-permeable (RGP) material, which allows oxygen to reach the cornea while maintaining structural integrity for extended daily wear. This material also provides a stable fit, which can be particularly beneficial for patients with irregular corneal shapes.

• Is the OP-3™ RGP Contact Lens intended for reuse, or is it strictly single-use? How does this affect its sterility and handling?

  The OP-3™ RGP Contact Lens is intended for single-use only, meaning each lens is designed for one-time wear and disposal. This ensures sterility is maintained for patient safety, as it eliminates the risk of cross-contamination or microbial buildup that can occur with reusable lenses. Single-use also simplifies handling, as there’s no need for cleaning or disinfection—just replace with a new lens each day under professional supervision.

• What should I consider when selecting a size or variant for the OP-3™ RGP Contact Lens, and how are these variants identified?

  The OP-3™ RGP Contact Lens comes in multiple sizes and variants, each corresponding to specific prescription requirements or corneal shapes. These variants are identified by unique registration numbers (e.g., 3005994941, 3043365583, etc.), which align with the device’s FDA classification under PMA number P920045. Selection should be based on a patient’s refractive error, corneal curvature, and clinical assessment by an eye care professional to ensure proper fit and vision correction.

• How should the OP-3™ RGP Contact Lens be stored to preserve its integrity and performance?

  The OP-3™ RGP Contact Lens must be stored according to the manufacturer’s guidelines to maintain its structural integrity and sterility. Since it is single-use, storage instructions likely pertain to unopened lenses (e.g., in a sealed, dry environment away from direct light or extreme temperatures). Improper storage could compromise the lens’s material properties or oxygen permeability, potentially affecting corneal health during use. Always follow the packaging instructions provided by Stellar Contact Lens, Inc.

• What regulatory pathway does the OP-3™ RGP Contact Lens follow, and what does this mean for clinicians or buyers?

  The OP-3™ RGP Contact Lens is regulated under FDA Premarket Approval (PMA), specifically with PMA number P920045 and classified under 21 CFR 886.5916. This means the device underwent rigorous clinical evaluation to ensure safety and effectiveness before approval. For clinicians or buyers, this indicates the lens meets stringent regulatory standards for daily-wear corneal refractive correction, though it remains subject to professional supervision during use, as outlined in its intended clinical and home-use applications.