Ultraviolet-Absorbing PMMA Anterior Chamber Intraocular Lens AC21B
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P010027 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 Anterior Chamber Intraocular Lens AC21B is a Class III medical device designed for the replacement of the human lens in the visual correction of aphakia. Manufactured from ultraviolet-absorbing polymethyl methacrylate (PMMA), this intraocular lens is intended for implantation in the anterior chamber of the eye, providing refractive correction following cataract extraction procedures.
This device is supplied in three overall diameters (12.0 mm, 13.0 mm, and 14.0 mm) and is approved for use in patients aged 60 years and older where a cataractous lens has been removed via primary intracapsular cataract extraction (ICCE) or extracapsular cataract extraction (ECCE). It is also indicated for secondary implant procedures, with specific considerations for structural reasons or comparative clinical outcomes. The device is regulated under FDA Premarket Approval (PMA) and adheres to regulatory requirements outlined in 21 CFR 886.3600.
Frequently asked questions
What is the purpose of the Anterior Chamber Intraocular Lens AC21B?
The Anterior Chamber Intraocular Lens AC21B is designed for the replacement of the human lens in the visual correction of aphakia, providing refractive correction following cataract extraction procedures.
In which patients is this intraocular lens indicated?
This lens is approved for use in patients aged 60 years and older where a cataractous lens has been removed via primary intracapsular cataract extraction (ICCE) or extracapsular cataract extraction (ECCE), as well as for secondary implant procedures.
What sizes are available for the Anterior Chamber Intraocular Lens AC21B?
The device is supplied in three overall diameters: 12.0 mm, 13.0 mm, and 14.0 mm to accommodate different anatomical requirements.
What material is used in the construction of this intraocular lens?
The lens is manufactured from ultraviolet-absorbing polymethyl methacrylate (PMMA), which provides the necessary optical properties and UV protection for the patient.
What is the regulatory status of this device?
The Anterior Chamber Intraocular Lens AC21B is regulated under FDA Premarket Approval (PMA) and adheres to regulatory requirements outlined in 21 CFR 886.3600.
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 | P010027 | Class III | Active |
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Manufacturer
- Manufacturer
- Aaren Scientific
Sources (1)
- FDA PMA P010027 24 fields · synced Oct 6, 2026