Recall Z-2398-2019— OCULOGICA

Name: FDA recall Z-2398-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-16

Class II · Terminated

Class II FDA medical device recall by OCULOGICA, initiated 2019-04-16, terminated 2020-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: EyeBOX Model OCL 02. Reason: A review of the user manual revealed that two precaution statements were missing..

Recalling firm: OCULOGICA
Classification: Class II
Status: Terminated
Initiated: 2019-04-16
Terminated: 2020-04-10
Firm location: New York, NY, United States

Product description

EyeBOX Model OCL 02

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.