MJP · Lens, Intraocular, Toric Optics
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | MJP |
|---|---|
| Device Name | Lens, Intraocular, Toric Optics |
| Regulation | 21 CFR 886.3600 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
Classification Rationale
Class III.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P910056S027 | enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T) | Bausch & Lomb, Inc. | Jun 8, 2018 | APPR |
| P030002S027 | TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | May 20, 2013 | APPR |
| P980040S039 | TECNIS TORIC 1-PEICE INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Apr 15, 2013 | APPR |
| P880091S014 | UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC | Staar Surgical Co. | Nov 4, 1998 | APPR |
Top Applicants
- Bausch & Lomb, Inc. — 2 clearances
- Johnson & Johnson Surgical Vision, Inc. — 1 clearance
- Staar Surgical Co. — 1 clearance
