Identity
- Trade Name
- STAARVISC II FDA PMA
- Generic Name
- AID, SURGICAL, VISCOELASTIC FDA PMA
Identifiers
- PMA Number
- P000046 FDA PMA
- FDA Product Code
- LZP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.4275 FDA PMA
- Regulation Number
- 886.4275 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
STAARVISC II Sodium Hyaluronate is a surgical viscoelastic aid indicated for use during surgery in the anterior and posterior segments of the human eye. It is designed to create and maintain anterior chamber depth and visibility, protect corneal endothelial cells and other intraocular tissues, minimize tissue interaction during surgical manipulation, and act as a vitreous substitute during retinal reattachment surgery.
The device is supplied by Anika Therapeutics, Inc. and is authorized under FDA PMA P000046. It is used in procedures including cataract extraction, intraocular lens implantation, corneal transplantation, glaucoma filtering surgery, and retinal reattachment. STAARVISC II preserves tissue integrity and visibility when filling the anterior and posterior segments following open sky procedures.
Frequently asked questions
What is STAARVISC II Sodium Hyaluronate used for?
STAARVISC II Sodium Hyaluronate is used during surgery in the anterior and posterior segments of the human eye to create and maintain anterior chamber depth, protect corneal endothelial cells and other intraocular tissues, minimize tissue interaction during surgical manipulation, and act as a vitreous substitute during retinal reattachment surgery.
Which procedures is STAARVISC II indicated for?
STAARVISC II is indicated for cataract extraction, intraocular lens (IOL) implantation, corneal transplantation surgery, glaucoma filtering surgery, and surgical procedures to reattach the retina.
Who manufactures STAARVISC II Sodium Hyaluronate?
STAARVISC II Sodium Hyaluronate is manufactured by Anika Therapeutics, Inc.
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 | P000046 | Class III | Active |
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Manufacturer
- Manufacturer
- Anika Therapeutics, Inc.
Sources (1)
- FDA PMA P000046 24 fields · synced Sep 18, 2026