Vistacryl 18(Kolfocon A) 32(Kolfocon B) RGP Lenses
PMA P880035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880035 | Date11 Aug 1993 | 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- Withdrawn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 (other material) - daily
- PMA Number
- FDA Product Code
- HQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S006 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Vistacryl 18(Kolfocon A) 32(Kolfocon B) RGP Lenses are rigid gas-permeable (RGP) contact lenses designed for daily wear. These lenses are classified as contact lenses made from other materials, intended for corneal or scleral correction and ocular surface management.
These lenses are supplied as single-use, non-sterile devices and are classified under FDA Product Code HQD. They are regulated under the FDA’s Premarket Approval (PMA) pathway, with PMA number P880035. The lenses are available in specific base curve and diameter combinations (18mm Kolfocon A and 32mm Kolfocon B) and must be handled and stored according to manufacturer guidelines to ensure proper use and sterility before application.
Questions
AI-generated answers, 18 Sep 2026
Are these lenses intended for overnight wear, or are they strictly for daily use only?
These lenses are explicitly designed for daily wear only, as stated in the description. The generic name ‘Lens, contact (other material) - daily’ confirms they are not approved for extended or overnight use. Always follow the manufacturer’s instructions to avoid complications.
How should I store these lenses before use, and are they sterile when packaged?
The lenses are supplied as non-sterile single-use devices, so they require sterilization or disinfection by the user before application. Storage must follow the manufacturer’s guidelines to maintain integrity until use. Never use them out of the original packaging without proper preparation.
What are the key size variations available for these RGP lenses, and how do I determine the right fit?
These lenses come in two primary base curve and diameter combinations: 18mm (Kolfocon A) and 32mm (Kolfocon B). The fit depends on the patient’s corneal curvature and ocular surface needs, so consultation with an eye care professional is essential to select the appropriate size for comfort and vision correction.
What regulatory pathway does this device follow, and how does that affect its availability?
The lenses are regulated under the FDA’s Premarket Approval (PMA) pathway with PMA number P880035, meaning they undergo rigorous review before approval. This ensures compliance with safety and efficacy standards, but availability may vary by region or jurisdiction based on local regulatory recognition of the PMA.
Can these lenses be reused, or are they strictly single-use?
These lenses are explicitly labeled as single-use, meaning they are intended for one-time wear only. Reusing them violates the manufacturer’s instructions and could pose significant health risks, such as infection or corneal damage. Always adhere to the single-use designation.