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ClearVisc Ophthalmic Viscosurgical Device (OVD)

by Bausch Health

PMA P200025

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P200025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200025 Date23 Mar 2021ApprovedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
AID, SURGICAL, VISCOELASTIC
PMA Number
FDA Product Code
LZP
Device Class
Class III
Regulation
21 CFR Part 886.4275
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ClearVisc Ophthalmic Viscosurgical Device (OVD) is a Surgical Aid, Viscoelastic (generic name) designed to assist in ophthalmic anterior segment procedures. It functions as a protective and space-maintaining medium during cataract extraction and intraocular lens (IOL) implantation, reducing trauma to ocular tissues and maintaining surgical clarity.

This device is supplied sterile and intended for single-use in controlled surgical environments. It is classified as a Class III medical device under FDA regulations (886.4275) and holds a Premarket Approval (PMA) designation (P200025). No MRI safety information is specified, and storage conditions are not detailed in the provided data.