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Terminated

EyeBOX Model OCL 02

FDA Recall Z-2398-2019 · Posted None

Recalling FirmOCULOGICA
Recall StatusTerminated
Product CodeQEA
Date Initiated2019-04-16
Date Terminated2020-04-10
Product Quantity3

Reason for Recall

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

Firm Action

IMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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