O-Perm F60 Rgp Contact Lens

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

Generic Name

Lens, contact (other material) - daily

PMA Number

P890046 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S025 (Normal 180 Day Track)

• O-Perm 30

  Class II

  FDA 510(k) K002703 Active Cleared 21 Nov 2000

• O-Perm 30 a Rigid Gas Permeable Contact Lens

  Class II

  FDA 510(k) K954124 Active Cleared 19 Mar 1996

• Is the O-Perm F60 RGP Contact Lens intended for daily wear or extended wear, and how does that affect its use?

  The O-Perm F60 is explicitly designed for daily-use, meaning it is intended to be removed and replaced each day rather than worn continuously. This classification aligns with its classification as a 'daily' rigid gas permeable (RGP) contact lens, ensuring it remains safe and effective for temporary corneal or scleral correction without prolonged exposure risks. Clinicians should follow standard daily-wear protocols to maintain ocular health.

• What storage and handling precautions must be taken for the O-Perm F60 RGP Contact Lens to ensure sterility and safety?

  Since the O-Perm F60 is supplied as a single-use, sterile product, it must be stored and handled according to sterile medical device protocols. This includes keeping the packaging intact until use, avoiding contamination, and adhering to manufacturer guidelines for shelf-life and environmental conditions (e.g., temperature, humidity) to preserve sterility and performance. Improper storage could compromise safety and efficacy.

• How is the regulatory approval process for the O-Perm F60 RGP Contact Lens structured, and what does the PMA number indicate?

  The O-Perm F60 underwent FDA Premarket Approval (PMA), a rigorous review process for high-risk medical devices. The PMA number P890046 confirms its regulatory clearance under this pathway, ensuring it meets stringent safety and effectiveness standards for temporary corneal or scleral correction. This approval is specific to the device’s intended use and design parameters, as outlined in the PMA submission.

• Are there multiple sizes or models available for the O-Perm F60 RGP Contact Lens, and how are they tailored for clinical use?

  While the provided data does not list specific base curve, diameter, or power measurements, the O-Perm F60 is categorized under FDA product code HQD for rigid gas permeable lenses, indicating it is available in various sizing and refractive parameters tailored for corneal or scleral correction. Clinicians should consult the manufacturer’s sizing charts or ordering guides to select the appropriate model for each patient’s prescription and ocular anatomy.

• Why is the O-Perm F60 RGP Contact Lens classified as a Class II device, and what does this mean for its use in clinical settings?

  The O-Perm F60 is classified as a Class II device under FDA regulations, meaning it has a moderate risk and requires special controls to ensure its safety and performance. This classification reflects its role in temporarily altering corneal refractive power while being non-disposable and requiring professional fitting by eye care specialists. Clinicians must follow established protocols for fitting, follow-up, and patient education to mitigate risks associated with its use.