Polymethylmetha-Crylate (pmma) Intraocular Lenses (iols)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- INTRAOCULAR LENS FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P860002 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
This device is a polymethylmethacrylate (PMMA) intraocular lens (IOL), a Class III ophthalmic implant designed for placement within the eye to replace the natural lens. It is manufactured by Bausch and Lomb and identified by the generic name 'intraocular lens' and product code HQL.
The lens is supplied as a sterile, single-use implant intended for surgical insertion in a clinical setting. It has received FDA Premarket Approval (PMA) under number P860002, with regulation number 886.3600, and is not indicated for MRI safety or reuse; all specifications regarding size, storage, and handling are defined by the manufacturer’s labeling and PMA submission.
Frequently asked questions
What material is the intraocular lens made of?
The intraocular lens is made of polymethylmethacrylate (PMMA), as explicitly stated in the device name and specifications.
Is this intraocular lens approved by the FDA?
Yes, the device has received FDA Premarket Approval (PMA) under application number P860002, as indicated in the AUTHORIZATIONS and pma_number fields.
What is the regulatory classification of this device?
The device is classified as a Class III medical device, as shown in the openfda field where device_class=3, and it falls under the ophthalmic medical specialty.
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 | P860002 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch and Lomb
- FDA Applicant
- Bausch & Lomb
Sources (1)
- FDA PMA P860002 24 fields · synced Sep 18, 2026