Health product recall

HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3)) (2019-09-06)

Starting date:
September 6, 2019
Posting date:
September 6, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70903



Last updated: 2019-09-11

Affected Products

HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3))

Reason

HFA review software version 1.0.1 which is compatible with HFA 830, 840, 850 and 860 models can possibly cause loss of test results/medical record information leading to a delay in treatment. There is a potential for a delay of treatment that could result in minor deterioration in a patient's vision (loss of less than a line on a visual acuity chart). The HFA review software is an accessory to the HFA instrument and the HFA instrument is not affected.

Affected products

HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3))

Lot or serial number

Not applicable.

Model or catalog number

HFA 830

HFA 840

HFA 850

HFA 860

Companies
Manufacturer

Carl Zeiss Meditec, Inc.

5160 Hacienda Drive

Dublin

94568

California

UNITED STATES