PMA P200025

Device
ClearVisc Ophthalmic Viscosurgical Device (OVD)
Applicant
Bausch Health
PMA number
P200025
Product code
LZP
Decision date
2021-03-23
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for the ClearVisc Ophthalmic Viscosurgical Device (OVD). ClearVisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:1) Extraction of a cataract; and2) Implantation of an intraocular lens (IOL).
Summary
<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf20/P200025B.pdf" target="_new">Summary of Safety and Effectiveness</a>

Current openFDA PMA Record#

Device
ClearVisc Ophthalmic Viscosurgical Device (OVD)
Applicant
Bausch Health
PMA number
P200025
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2021-03-23
Decision code
APPR
Date received
2020-04-20
Approval order statement
Approval for the ClearVisc Ophthalmic Viscosurgical Device (OVD). ClearVisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:1) Extraction of a cataract; and2) Implantation of an intraocular lens (IOL).