Oculus Optikgeraete GMBH
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2484-2023 | Class II | Oculus Myopia Master , Ref 68100, CE 0123 | August 8, 2023 |
| Z-2482-2023 | Class II | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | August 8, 2023 |
| Z-2483-2023 | Class II | Oculus Pentacam AXL , Ref 70100, CE 0123 | August 8, 2023 |
| Z-1674-2022 | Class II | Pentacam HR REF 70900. Used to image the anterior segment of the eye. | July 8, 2022 |
| Z-1672-2022 | Class II | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. | July 8, 2022 |
| Z-1673-2022 | Class II | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye. | July 8, 2022 |
| Z-0635-2018 | Class II | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The fir | November 21, 2017 |