Identity
- Trade Name
- SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P910056 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 Envista Hydrophobic Intraocular Lens is an ophthalmic device designed as a posterior chamber intraocular lens. It is manufactured by Bausch & Lomb, Inc. and features a silicone material with UV-absorbing properties.
This device is supplied as a sterile, single-use implant intended for use in ophthalmic surgical settings. It holds FDA PMA authorization (P910056) and is classified as a Class III medical device under regulation number 886.3600.
Frequently asked questions
What type of device is the Envista Hydrophobic Intraocular Lens?
The Envista Hydrophobic Intraocular Lens is an ophthalmic device classified as an intraocular lens, specifically designed for placement in the posterior chamber of the eye during cataract surgery or refractive lens exchange.
Is the Envista Hydrophobic Intraocular Lens reusable or single-use?
The Envista Hydrophobic Intraocular Lens is supplied as a sterile, single-use implant and is not intended for reuse, as confirmed by its regulatory specifications and device classification.
What regulatory authorization does the Envista Hydrophobic Intraocular Lens have?
The Envista Hydrophobic Intraocular Lens has received FDA Premarket Approval (PMA) under application number P910056, which was granted on January 17, 1992, and is listed under regulation number 886.3600 for intraocular lenses.
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 | P910056 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P910056 24 fields · synced Oct 6, 2026