FDA Device recall Z-2515-2023
ISee Ortho-K Lens
- FDA Device
- Class II
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of ISee Ortho-K Lens by Paragon Vision Sciences, citing manufactured lenses are not covered by existing FDA approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2515-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-26 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Paragon Vision Sciences |
| Distribution | US |
Product
ISee Ortho-K Lens
Reason
Manufactured lenses are not covered by existing FDA approval
Identifiers
| code_info | All Lots , DI-B22208 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2515-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.