ClearVisc Ophthalmic Viscosurgical (OVD)

FDA Premarket Approval P200025

Pre-market Approval Supplement Details

Approval for the clearvisc ophthalmic viscosurgical device (ovd). Clearvisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:• extraction of a cataract• implantation of an intraocular lens (iol)

DeviceClearVisc Ophthalmic Viscosurgical (OVD)
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch Health
Date Received2020-04-20
Decision Date2021-03-23
PMAP200025
SupplementS
Product CodeLZP 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Bausch Health 400 Somerset Corporate Boulevard bridgewater, NJ 08807
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P200025Original Filing

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