FDA recall Z-0362-2025

Topcon Medical Systems, Inc. · Class II · device

Product

The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

Reason for recall

The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-09-17
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakland, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2025