Paraperm O2 Contact Lens Clear & Blue
by Dupont Legal
PMA P820061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820061 | Date6 Dec 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Lens, contact (polymethylmethacrylate)
- PMA Number
- FDA Product Code
- HPX
- Device Class
- U
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The Paraperm O₂ Contact Lens Clear & Blue is a rigid gas permeable contact lens made from a thermoset copolymer of siloxane and polymethylmethacrylate. Classified as a lens, contact (polymethylmethacrylate), it is designed for ophthalmic use, providing a tinted option for improved lens visibility during handling.
These lenses are intended for daily wear and are supplied as either lathe-cut or molded, featuring spherical, aspheric, bifocal, toric, or bitoric surfaces. Authorized under FDA Premarket Approval (PMA P820061), they are non-sterile and reusable, requiring proper cleaning and maintenance as per manufacturer guidelines. The product code HPX categorizes it under the OpenFDA classification for rigid gas permeable contact lenses.
Other devices from Dupont Legal
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses reusable, and if so, how should they be maintained?
Yes, the Paraperm O₂ Contact Lens Clear & Blue is designed for reuse. Since they are non-sterile, proper cleaning and maintenance are required to ensure safety and longevity. Follow the manufacturer’s guidelines for cleaning, disinfecting, and storing the lenses to prevent damage or contamination, as these lenses are intended for daily wear.
What types of surfaces are available for these contact lenses, and how does that affect their use?
These lenses come in multiple surface types, including spherical, aspheric, bifocal, toric, and bitoric designs. The choice of surface affects how the lens fits the eye and corrects vision—spherical lenses provide basic vision correction, while toric and bitoric lenses address astigmatism, and bifocal lenses offer multiple focal points for near and distance vision.
Are these lenses available in different colors, and what purpose does the tint serve?
Yes, these lenses are available in a tinted option called Clear & Blue. The tint improves visibility during handling, making it easier for patients or practitioners to insert, remove, or inspect the lens without losing it in the eye.
How were these lenses approved by the FDA, and what does that mean for their use?
The Paraperm O₂ Contact Lens Clear & Blue received FDA Premarket Approval (PMA P820061), meaning the device underwent rigorous review to ensure safety, effectiveness, and compliance with regulatory standards. This approval confirms the lens meets FDA requirements for rigid gas permeable contact lenses, allowing authorized practitioners to prescribe them for daily wear.