Akreos Posterior Chamber Intraocular Lens, Model AO60
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P060022 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 Akreos Posterior Chamber Intraocular Lens, Model AO60, is an aspheric intraocular lens designed for primary implantation to correct aphakia in adult patients following cataractous lens removal via phacoemulsification. It is intended for placement within the capsular bag, providing optical correction for visual restoration.
This device is supplied sterile and is classified as a Class III medical device under FDA regulations. It is intended for single-use and must be implanted by a qualified ophthalmic surgeon in a sterile operating environment. The lens adheres to MRI safety standards for use in magnetic resonance imaging procedures. Authorized under FDA PMA (P060022), it complies with regulatory requirements for ophthalmic intraocular lenses as outlined in 21 CFR 886.3600.
Frequently asked questions
What is the Akreos intraocular lens specifically designed to correct, and how is it implanted?
The Akreos Posterior Chamber Intraocular Lens (Model AO60) is designed to correct aphakia—visual impairment caused by the absence of a natural lens—in adult patients after cataractous lens removal via phacoemulsification. It is intended for **primary implantation within the capsular bag**, providing optical correction to restore vision. The procedure must be performed by a qualified ophthalmic surgeon in a sterile operating environment.
Is the Akreos lens reusable, or is it meant for single-use only?
The Akreos Posterior Chamber Intraocular Lens is explicitly classified as a **single-use device**. It is supplied sterile and must not be reused after implantation to ensure patient safety and compliance with regulatory standards.
Can this lens be used with MRI procedures, and why does that matter?
Yes, the Akreos lens adheres to **MRI safety standards**, meaning it can be safely used in magnetic resonance imaging procedures. This is important because some intraocular lenses may contain metallic components or materials that could interfere with MRI scans or pose risks during the procedure.
How is the Akreos lens supplied, and what should clinicians verify before use?
The lens is supplied **sterile** and ready for immediate use in a sterile operating environment. Clinicians should confirm the sterility seal is intact and verify the lens is the correct model (AO60) for placement within the capsular bag, as misplacement could compromise visual outcomes.
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 | P060022 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P060022 24 fields · synced Sep 18, 2026