CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report

EyeBOX Model OCL recalled by Oculogica

Oculogica is recalling EyeBOX Model OCL 02, distributed in Maryland, New York. The recall was initiated on 16 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers TT003, TT004, TT005
Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2398-2019
FDA event ID
82922
Recalling firm
Oculogica, New York, NY
Classification
Class II
Status
Terminated
Recall initiated
16 Apr 2019
FDA classified
27 Aug 2019
Reported
4 Sep 2019
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

16 Apr 2019Recall initiated by company
27 Aug 2019Classified by FDA+133 days
4 Sep 2019Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A review of the user manual revealed that two precaution statements were missing.

Product as listed by the FDA

EyeBOX Model OCL 02

Where it was distributed

The products were distributed to the following US states: MD and NY

MarylandNew York

Questions about this recall

Is EyeBOX Model OCL 02 recalled?

Yes. Oculogica recalled EyeBOX Model OCL 02 on 16 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-2398-2019.

Why was it recalled?

A review of the user manual revealed that two precaution statements were missing.

Which lots are affected?

Serial Numbers TT003, TT004, TT005

Where was it sold?

The products were distributed to the following US states: MD and NY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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