FDA-Device2023-07-05Class II
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Ellex Medical Pty Ltd.
Hazard
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
Sold states
US nationwide/ Worldwide Distribution
Affected count
57 systems in total (6 units shipped to United States)
Manufactured in
3-4 Second Ave, N/A, Mawson Lakes, N/A, Australia
Products
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1971-2023Don't want to check this manually?
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