FDA device listing
Intraocular Lens
FDA device listing 1618868863 · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
|---|---|
| Owner/operator number | 10053607 |
| Premarket submissions | P980040 |
| Product codes | HQL, MFK, MJP, POE |
| Device names | HQL - Intraocular Lens, MFK - Lens, Multifocal Intraocular, MJP - Lens, Intraocular, Toric Optics, POE - Extended Depth Of Focus Intraocular Lens |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.3600 |
| Review panels | Ophthalmic |
| Registered establishments | AMO GRONINGEN BV, AMO PUERTO RICO MANUFACTURING, INC, Johnson & Johnson Surgical Vision, Inc. |
| Establishment registrations | 2648035, 9614546, 3012236936 |
| FEI numbers | 2648035, 3004651700, 3012236936 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database