Date Initiated by Firm |
April 16, 2019 |
Create Date |
August 28, 2019 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number |
Z-2398-2019 |
Recall Event ID |
82922 |
Product Classification |
Brain injury adjunctive interpretive oculomotor assessment aid - Product Code QEA
|
Product |
EyeBOX Model OCL 02 |
Code Information |
Serial Numbers TT003, TT004, TT005 |
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 |
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 |
Total Product Life Cycle |
TPLC 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.
|