VISUMAX 800

Additional Manufacturer Narrative

THE PRIMARY ROOT CAUSE OF THE UNSUCCESSFUL SMILE PROCEDURE WAS INADEQUATE ADHERENCE TO THE RECOMMENDED USER WORKFLOW AND SURGICAL DECISION-MAKING BY THE TREATING SURGEON. DESPITE A CLEARLY ABNORMAL AND INHOMOGENEOUS BUBBLE PATTERN AND MARKED DIFFICULTY IN ACCESSING AND IDENTIFYING THE DISSECTION PLANES, THE SURGEON DECIDED TO PROCEED WITH THE TREATMENT INSTEAD OF ABORTING, CONTRARY TO APPLICATION TRAINING AND GUIDELINES; THE SURGEON SHOULD HAVE REALIZED AT THIS MOMENT THAT AN OPENING/DISSECTION OF THE LENTICULE WILL BE/MIGHT BE VERY DIFFICULT OR IMPOSSIBLE. THE POSTERIOR PLANE WAS LIKELY MISIDENTIFIED AS THE ANTERIOR PLANE, AND VIGOROUS MANIPULATION UNDER POOR CUT CONDITIONS LED TO TISSUE TRAUMA AND A PERIPHERAL CAP TEAR, SO OVERALL IT'S A USER ERROR. IN ADDITION, THE MANDATORY FORCED SYSTEM CHECK PRIOR TO TREATMENT, AS SPECIFIED IN THE APPLICATION BULLETIN NO. 16 FOR OUTDATED SOFTWARE VERSION 1.2.3, WAS NOT PERFORMED, ALLOWING AN EXISTING LASER BEAM DRIFT TO REMAIN UNCORRECTED. THE TECHNICAL BEAM DRIFT OF THE LASER HEAD AND THE OLDER OUTDATED SOFTWARE VERSION 1.2.3 CONTRIBUTED TO SUBOPTIMAL CUT QUALITY, BUT THE CONTINUATION OF SURGERY UNDER THESE CONDITIONS WAS A DECISIVE FACTOR FOR THE ADVERSE CLINICAL OUTCOME. CONSEQUENTLY, RETRAIN USER AND SHOW USER THAT BAD BUBBLE LAYERS ARE A CONTRAINDICATION TO SURGERY.

Description of Event or Problem

THE CUSTOMER REPORTED AN UNSUCCESSFUL SMILE PROCEDURE. DURING THE PROCEDURE, THE SURGEON EXPERIENCED SIGNIFICANT DIFFICULTY ENTERING THE INCISION AND IDENTIFYING THE ANTERIOR AND POSTERIOR DISSECTION PLANES. AT THE TIME OF LASER FIRING FOR LENTICULE AND CAP CUT, THE BUBBLE PATTERN APPEARED NON-HOMOGENEOUS, WITH MULTIPLE BLACK SPOTS NOTED. DESPITE THE ABNORMAL LASER PATTERN, THE SURGEON PROCEEDED WITH THE TREATMENT. AFTER CONSIDERABLE EFFORT, ACCESS THROUGH THE INCISION WAS EVENTUALLY ACHIEVED AND THE SURGEON BELIEVED THE ANTERIOR PLANE HAD BEEN DISSECTED. HOWEVER, THE POSTERIOR PLANE COULD NOT BE IDENTIFIED OR SEPARATED. FOLLOWING VIGOROUS MANIPULATION ON THE EYE RESULTING IN BLEEDING AND INFLAMMATION, THE PROCEDURE WAS ABANDONED AND THE PATIENT WAS DISCHARGED.