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Iridex became aware of a complaint involving a patient experiencing cardiac arrest following a transscleral cyclophotocoagulation procedure using a cyclo g6 laser console with a micropulse p3 probe.The physician communicated to the iridex representative that the patient recovered and was discharged.The most likely cause for this event is suspected to be adverse reaction to general anesthesia potentially in combination with patient's health conditions.The laser therapy is not believed to have caused or contributed to this event.However, a definitive conclusion on cause could not be determined.No failure analysis was performed on the device as it was not returned to iridex.No malfunctions or errors were observed during treatment.A review of complaint history from january 2017 to current was completed and one similar incident was identified.During this period over 108,000 procedures were completed with cyclo g6 using mp3 probe.The ifu for the micropulse p3 probe references use of local anesthesia.In the ifu under the anesthesia section "typically an anesthesia block is used during these procedures".Attempts to contact the physician for additional information by phone, voicemail and email were not returned.Therefore, additional patient information is not available.This complaint does not appear to be a part of an increasing trend.Although two complaints have been received, both complaints reference use of general anesthesia to sedate the patient and neither complaint alleges a deficiency or malfunction with the laser system.
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