MalfunctionMMQ

ZEISS ATLAS TOPOGRAPHER

Received Feb 13, 2025

Report MW5166121 · MDR key 21376820

Device

Generic name

Topographer, Corneal, Ac-powered

Manufacturer

Carl Zeiss Meditec Ag (jena)

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE ZEISS ATLAS TOPOGRAPHER INSTRUMENTS DO NOT PROVIDE SOFTWARE PATCHING TO PROTECT AGAINST SECURITY VULNERABILITIES. THE DEVICES DOES NOT COMPLY WITH THE "PATCH ACT OF 2022" WHICH STATES "THE MANUFACTURER SHALL HAVE A PLAN TO APPROPRIATELY MONITOR, IDENTIFY, AND ADDRESS IN A REASONABLE TIME POSTMARKET CYBERSECURITY VULNERABILITIES AND EXPLOITS".