FDA Device recall Z-2398-2019
EyeBOX Model OCL 02
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of EyeBOX Model OCL 02 by Oculogica, citing A review of the user manual revealed that two precaution statements were missing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2398-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-16 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Oculogica |
| Distribution | MD, NY |
Product
EyeBOX Model OCL 02
Reason
A review of the user manual revealed that two precaution statements were missing.
Identifiers
| code_info | Serial Numbers TT003, TT004, TT005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2019%22
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