One-Piece Posterior Chamber Intraocular Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P870073 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
- APWD FDA PMA
The One-Piece Posterior Chamber Intraocular Lenses are a type of intraocular lens designed for implantation within the eye’s posterior chamber following cataract surgery or aphakia correction. These lenses are intended to restore visual function by replacing the natural lens, providing clear vision for the patient by focusing light onto the retina.
These lenses are supplied sterile and intended for single-use. They are classified as Class III devices under FDA regulations (886.3600) and have received FDA Premarket Approval (PMA P870073). The product is distributed in sterile packaging, requiring aseptic handling prior to surgical implantation. No specific MRI safety information is provided in the data.
Frequently asked questions
Are these lenses reusable or intended for single-use only, and what does that mean for surgical preparation?
These lenses are explicitly designed for single-use only and are supplied sterile in their packaging. This means each lens is intended for one surgical procedure and must be handled with aseptic techniques to maintain sterility before implantation. Reusing them would violate the manufacturer’s instructions and could compromise patient safety.
What types of vision correction procedures are these lenses approved for, and how do they differ from other intraocular lenses?
These one-piece posterior chamber intraocular lenses are approved for implantation in the eye’s posterior chamber following cataract surgery or to correct aphakia (absence of the natural lens). Unlike some other lenses, they are designed as a single, unified piece for stability and clarity, focusing light directly onto the retina to restore visual function without the need for additional adjustments.
How should these lenses be stored before use, and what precautions should be taken to ensure they remain sterile?
The lenses are supplied in sterile packaging, so they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility. Once opened, the lens must be implanted promptly under aseptic conditions, as no additional sterilization is recommended.
What regulatory pathway was followed for approval, and how does this affect their use in clinical practice?
These lenses received FDA Premarket Approval (PMA P870073), which is the highest level of regulatory review for medical devices. This approval confirms their safety and effectiveness for the intended use in cataract surgery or aphakia correction. Clinicians can rely on this approval when selecting the lens for procedures, though adherence to the manufacturer’s instructions remains critical for proper implantation.
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 | P870073 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P870073 24 fields · synced Sep 18, 2026