SUMMUS MEDICAL LASER - HORIZON

Description of Event or Problem

THE TECHNICIAN WAS CHANGING THE LENS ON THE LASER SYSTEM. DURING THIS PROCESS THE LASER INADVERTENTLY ACTIVATED, AND THE LASER BEAM STRUCK THE TECHNICIAN IN THE EYE. THE TECHNICIAN WAS NOT WEARING THE SAFETY GLASSES AS REQUIRED PER THE USER MANUAL.

Additional Manufacturer Narrative

COMPLAINT (B)(4): ON THE MORNING OF JUNE 10, 2025, A TECHNICIAN WAS CHANGING THE LENS ON THE HORIZON LASER SYSTEM. ACCORDING TO THE DOCTOR, DURING THIS PROCESS THE LASER INADVERTENTLY ACTIVATED, AND THE BEAM STRUCK THE TECHNICIAN IN THE EYE. THE TECHNICIAN REPORTED EXPERIENCING A HEADACHE AND BLURRED VISION. THESE SYMPTOMS RESOLVED BY THE AFTERNOON OF THE SAME DAY, AND THERE HAVE BEEN NO FURTHER REPORTS OR COMMUNICATIONS REGARDING ONGOING SYMPTOMS. DURING DISCUSSION WITH THE DOCTOR, IT WAS DETERMINED THAT THE TECHNICIAN HAD LEFT THE DEVICE IN AN ACTIVE STATE WHILE CHANGING THE LENS. UPON REMOVAL OF THE LENS, THE TECHNICIAN INADVERTENTLY PRESSED THE ACTIVATION BUTTON (FINGER SWITCH) ON THE HANDPIECE, WHICH RESULTED IN THE LASER FIRING. THE TECHNICIAN WAS NOT WEARING PROTECTIVE SAFETY GOGGLES AT THE TIME, AS REQUIRED BY THE USER MANUAL. THE INVESTIGATION INDICATES THE DEVICE FUNCTIONED AS DESIGNED. THE INCIDENT RESULTED FROM USER ERROR, INCLUDING: FAILURE TO FOLLOW SAFETY INSTRUCTIONS (E.G., WEARING PROTECTIVE GOGGLES), ATTEMPTING TO CHANGE THE LENS WHILE THE DEVICE WAS IN AN ACTIVE OR READY STATE AND ACCIDENTAL PRESSING OF THE FINGER SWITCH.