Jacksonville, FL, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Class II | Ophthalmic | 2 | 2021-11-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-06-12 | Class II | Ongoing | Z-2163-2025 | ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL | — | Due to defects (bubbles/voids) identified during standard finished goods testing |
| 2021-05-06 | Class II | Terminated | Z-1865-2021 | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50 | — | Potential that a limited number of individual contact lens packages have an incomplete packaging seal. |