Gilbert, AZ, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | Class II | Ophthalmic | 1 | 2023-05-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-06-26 | Class II | Ongoing | Z-2516-2023 | Fargo Ortho-K Lens | — | Manufactured lenses are not covered by existing FDA approval |
| 2023-06-26 | Class II | Ongoing | Z-2515-2023 | ISee Ortho-K Lens | — | Manufactured lenses are not covered by existing FDA approval |