One-Piece Posterior Chamber Intraocular Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P840039 FDA PMA
- FDA Product Code
- HQL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.3600 FDA PMA
- Regulation Number
- 886.3600 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The One-Piece Posterior Chamber Intraocular Lenses are a class III medical device designed for implantation in the eye to replace the natural crystalline lens following cataract extraction or other indications requiring lens removal. These lenses are crafted from polymethyl methacrylate (PMMA) and are engineered to restore visual function by focusing light onto the retina, correcting refractive errors such as aphakia or presbyopia.
These lenses are supplied sterile and intended for single-use in ophthalmic surgical procedures. They are manufactured in various optical powers and sizes to accommodate different patient anatomies and refractive needs. The device is regulated under FDA Premarket Approval (PMA) with the PMA number P840039, adhering to the classification and requirements outlined in regulation number 886.3600. Storage and handling must comply with sterile surgical instrument protocols to ensure integrity prior to use.
Frequently asked questions
Are these lenses reusable or intended for single-use in surgery, and how should they be handled to maintain sterility?
These lenses are explicitly designed for **single-use only** in ophthalmic procedures. They are supplied sterile, so handling must follow strict sterile surgical instrument protocols to preserve integrity before implantation. Avoid contamination by using sterile packaging and tools, and adhere to standard aseptic techniques during surgery.
What materials are these intraocular lenses made from, and how does that affect their performance?
The lenses are crafted from **polymethyl methacrylate (PMMA)**, a durable, biocompatible material that provides optical clarity and stability. PMMA is chosen for its ability to focus light effectively onto the retina, correcting refractive errors like aphakia or presbyopia after cataract surgery or lens removal. Its rigidity also ensures consistent placement within the posterior chamber.
What optical powers and sizes are available for these lenses, and how do they accommodate different patient needs?
The lenses come in **multiple optical powers and sizes** to match diverse patient anatomies and refractive requirements. While exact specifications aren’t listed here, the variety ensures compatibility for aphakic or presbyopic patients, allowing surgeons to select the appropriate power and haptic design for optimal visual correction post-implantation.
How is the regulatory approval process for these lenses structured, and what does the PMA number indicate?
These lenses undergo **FDA Premarket Approval (PMA)**, a rigorous review process for Class III devices. The PMA number **P840039** confirms their compliance with FDA regulations (e.g., 886.3600) and demonstrates that clinical performance, safety, and manufacturing standards have been validated by the agency. This approval ensures the lenses meet stringent requirements for intraocular use.
Do these lenses absorb ultraviolet (UV) light, and if so, does that affect their suitability for certain patients?
The lenses are available in **both UV-absorbing and non-UV-absorbing versions**, as indicated by the trade name. UV-absorbing models may reduce potential long-term retinal exposure to harmful UV rays, which could be preferable for patients with high outdoor exposure or specific ocular sensitivities. The choice depends on clinical judgment and patient-specific factors.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P840039 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P840039 24 fields · synced Oct 6, 2026