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)
| Device | ClearVisc Ophthalmic Viscosurgical (OVD) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch Health |
| Date Received | 2020-04-20 |
| Decision Date | 2021-03-23 |
| PMA | P200025 |
| Supplement | S |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200025 | Original Filing |