Complaints handling
Please contact your local distributor in case of any incident related to product defects (hardware
defects or software bugs) or adverse events (which does not necessarily have a causal association
to the product). It is recommended for a user to report all the known facts about the incident. Upon
receipt of any serious incident with serious health impact for the patient or user (serious adverse
events), Interacoustics shall ensure that the regulatory authority in patient's home country is
informed according to the vigilance requirements. Interacoustics shall handle all the product complaints and
adverse events as per the internal procedure.
D-0126472-A – 2020/08
VisualEyes™ 505 Instructions for Use -US
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