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Health Canada Medical devices

Integre Pro

Issued April 5, 2023
Issue
Ellex was recently made aware of a potential safety issue impacting a small number of Integre Pro/Integre Pro Scan lasers . This was reported as a single event during servicing with no injury; when using a laser-indirect-ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may exit through the slit lamp output port (SDS) and get emitted from the objective lens when the laser is fired. The cause was traced to an incorrect assembly of a sub-module in the laser cavity system. Recall start date: March 13, 2023
Hazard description
Performance
Product
Product name
Integre Pro
Reference
ID
RA-73457