Provisc Ophthalmic Viscoelastic Device (OVD)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Provisc Ophthalmic Viscosurgical Device (Ovd)

Trade Name

Provisc(Tm)Viscoelastic Preparation

Generic Name

AID, SURGICAL, VISCOELASTIC

PMA Number

P890047 ↗

FDA Product Code

LZP

Device Class

Class III

Regulation

21 CFR Part 886.4275

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

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• What is the primary purpose of the Provisc Ophthalmic Viscoelastic Device during surgery?

  The Provisc Ophthalmic Viscoelastic Device is designed to maintain the depth of the anterior chamber and protect ocular tissues during ophthalmic surgical procedures. It acts as an intraocular viscoelastic substance to help surgeons manipulate intraocular structures more safely, reduce trauma, and enhance visibility within the eye.

• Is the Provisc Ophthalmic Viscoelastic Device intended for reuse, or is it meant for single-use only?

  The Provisc Ophthalmic Viscoelastic Device is explicitly supplied as a sterile, single-use product. This ensures patient safety and maintains sterility standards required for ophthalmic surgeries, where contamination risks must be minimized.

• How is this device regulated, and what does its PMA designation mean?

  The Provisc Ophthalmic Viscoelastic Device holds a **Premarket Approval (PMA)** designation (PMA Number: P890047), which is the highest level of regulatory review for medical devices in the U.S. This means it underwent rigorous scientific and clinical evaluation by the FDA to demonstrate safety and effectiveness before approval. It is classified as a **Class III** device under FDA regulations (886.4275), indicating it supports or sustains human life or is of substantial importance in preventing impairment of human health.

• What types of ophthalmic procedures is this device commonly used for?

  While the device’s **advisory committee description** and **medical specialty** are both categorized under **Ophthalmic**, its **generic name** specifies it as a **Surgical Aid, Viscoelastic**. This type of device is primarily used during **cataract surgery** and other anterior segment procedures where maintaining chamber depth, protecting corneal endothelium, and improving surgical visibility are critical. It is not intended for any specific clinical indication but rather as a supportive tool during these surgeries.

• What product codes or registration numbers should be referenced when ordering or tracking this device?

  The Provisc Ophthalmic Viscoelastic Device is distributed under the **product code LZP**. For regulatory tracking or inventory purposes, it is associated with multiple **FEI numbers**, including 3007093114, 3015456951, and others listed in the specifications. These identifiers help ensure proper ordering, compliance, and traceability in healthcare settings.