Z-2398-2019Class II

EyeBOX Model OCL 02

Name: Z-2398-2019 EyeBOX Model OCL 02
Creator: Oculogica
Published: 2019-04-16
License: https://open.fda.gov/license/

Oculogica Inc. / initiated 2019-04-16 / Terminated / root cause: labeling and UDI

FDA source

OCULOGICA began a recall of EyeBOX Model OCL 02 on 2019-04-16. FDA classified it as Class II and gives the reason as "A review of the user manual revealed that two precaution statements were missing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2398-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-16
Posted: 2019-08-28
Terminated: 2020-04-10
Recalling firm: Oculogica Inc.
Product: EyeBOX Model OCL 02
Product code: QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Reason for recall: A review of the user manual revealed that two precaution statements were missing.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: IMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19.
Quantity in commerce: 3
Distribution: The products were distributed to the following US states: MD and NY
Product codes and lots: Serial Numbers TT003, TT004, TT005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2398-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2398-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code QEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)