MAUDE manufacturer profile

VISIONSENSE LTD. · OWN

MAUDE profile for Confocal Optical Imaging

Key facts

Manufacturer VISIONSENSE LTD.
Manufacturer group VISIONSENSE LTD.
Product code OWN
Product code name Confocal Optical Imaging

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Thermal Decomposition of Device, Smoking, Device Displays Incorrect Message, Material Integrity Problem, Insufficient Information, Material Puncture/Hole, Melted Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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