Skip to content

StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)

by Bausch Health Companies, Inc.

PMA P220009

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 P220009↗

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 NumberP220009 Date22 Feb 2023ApprovedStatusActive

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  • Withdrawn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 StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) is classified as a surgical aid, specifically a viscoelastic substance used in ophthalmic procedures. It functions as a protective medium during anterior segment surgery, maintaining corneal integrity and facilitating manipulation of ocular tissues.

These devices are supplied sterile and intended for single-use in cataract extraction and intraocular lens implantation. They are regulated under FDA Premarket Approval (PMA) and fall under device classification 3, adhering to regulation number 886.4275. Each device is packaged individually for sterile use in controlled surgical environments.