Rayner Intraocular Lenses Ltd
FDA Regulatory Profile
Rayner Intraocular Lenses Ltd appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1338-2022, Class II) was initiated on May 13, 2022. Its most recent 510(k) clearance was granted on December 18, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1338-2022 | Class II | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with | May 13, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | December 18, 2014 |
| K141091 | RAYSERT PLUS INJECTOR | May 28, 2014 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE | March 27, 2014 |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | December 4, 2009 |