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U.S. Department of Health and Human Services

Class 2 Device Recall EyeBOX Model OCL 02

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 Class 2 Device Recall EyeBOX Model OCL 02see related information
Date Initiated by FirmApril 16, 2019
Create DateAugust 28, 2019
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-2398-2019
Recall Event ID 82922
Product Classification Brain injury adjunctive interpretive oculomotor assessment aid - Product Code QEA
ProductEyeBOX Model OCL 02
Code Information Serial Numbers TT003, TT004, TT005
FEI Number 3014535677
Recalling Firm/
Manufacturer		 OCULOGICA
33 Irving Pl
New York NY 10003-2332
Manufacturer Reason
for Recall		A review of the user manual revealed that two precaution statements were missing.
FDA Determined
Cause 2		Labeling design
ActionIMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19.
Quantity in Commerce3
DistributionThe products were distributed to the following US states: MD and NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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