Identity
- Trade Name
- CHAMBER LENS MODELS 101, 101B, 101T FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P790027 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
- PMA Supplement
- S006 FDA PMA
The Model 3091B is an intraocular lens (IOL), a prosthetic device implanted within the eye to replace the natural lens following cataract surgery or to correct refractive errors. It is designed to restore visual function by focusing light onto the retina, enabling clear vision for the patient. This device is classified as a Class III medical device under FDA regulations, requiring premarket approval (PMA) due to its direct involvement in surgical implantation and long-term ocular function.
This intraocular lens is supplied as a sterile, single-use device intended for surgical implantation by ophthalmologists in a controlled operating room environment. The Model 3091B features 5.0 mm optics and is authorized under FDA PMA number P790027, with subsequent supplements. It is not MRI-compatible without specific manufacturer confirmation and must be handled according to sterile surgical protocols. Storage and handling instructions are detailed in the accompanying packaging to ensure device integrity prior to use.
Frequently asked questions
What is the primary use of the Model 3091B IOL, and how does it differ from other intraocular lenses in terms of optics?
The Model 3091B is designed specifically to replace the natural lens in the eye after cataract surgery or to correct refractive errors, restoring clear vision by focusing light onto the retina. Its key distinction lies in the **5.0 mm optics**, which may offer a different optical power or light distribution compared to lenses with varying optic sizes. This design choice is intended to optimize visual acuity for patients, but the exact clinical benefits depend on the surgeon’s selection based on patient-specific needs.
Is the Model 3091B intended for reuse, or is it strictly single-use? How should it be handled to maintain sterility?
The Model 3091B is **strictly a single-use device**, meaning it is not intended for reuse after a single surgical procedure. It is supplied sterile and must be handled using **aseptic techniques** in a controlled operating room environment. The packaging includes detailed storage and handling instructions to ensure device integrity before use, emphasizing sterile protocols to prevent contamination.
What considerations should a clinician keep in mind regarding MRI compatibility when using the Model 3091B?
The Model 3091B is **not MRI-compatible by default**, and clinicians must confirm compatibility with the manufacturer before subjecting patients to MRI scans. This is critical because intraocular lenses may interact with magnetic fields, potentially causing harm or image artifacts. Always verify with Bausch and Lomb prior to MRI procedures.
How was the regulatory pathway for the Model 3091B established, and what does the PMA number indicate?
The Model 3091B follows the **FDA Premarket Approval (PMA) pathway**, a rigorous process for Class III devices due to their direct involvement in surgical implantation and long-term ocular function. The **PMA number P790027** (with subsequent supplements like S006) indicates that this device has undergone FDA review and approval for safety and effectiveness. This pathway ensures that the lens meets stringent standards before clinical use.
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 | P790027 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch and Lomb
- FDA Applicant
- Bausch & Lomb
Sources (1)
- FDA PMA P790027 24 fields · synced Sep 18, 2026