VISUMAX

Additional Manufacturer Narrative

THE MOST POSSIBLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THERE IS NO INDICATION THAT ANY MALFUNCTION OCCURRED DURING THE TWO VISUMAX PROCEDURES - ORIGINAL SMILE OD TREATMENT AND 3RD TREATMENT WITH CIRCLE FUNCTION - WHICH COULD EXPLAIN THE REPORTED OUTCOME ON PATIENT EYE OD. BESIDE THIS, THE 2ND SURGERY AND THE 4TH SURGERY HAD BEEN EXECUTED MANUALLY WITHOUT ANY CONTRIBUTION OF THE VISUMAX DEVICE. A NUMBER OF FACTORS NOT RELATED TO THE DEVICE MAY HAVE INFLUENCED THE TREATMENT OUTCOME. NOT ALL ARE CONTROLLED BY THE MANUFACTURER.

Description of Event or Problem

IT IS REPORTED THAT, THE INITIAL SMILE SURGERY (B)(6) 2025 WAS PERFORMED WITHOUT ANY ISSUES ON THE LEFT EYE (OS) BUT THE RIGHT EYE (OD) ENCOUNTERED COMPLICATIONS WITH THE LENTICULE, WHICH TORE AND WAS REMOVED IN SEVERAL PIECES. THE 2ND SURGERY RE-OPERATION (B)(6) 2025 WAS THE ATTEMPT TO REMOVE THE LENTICULE RESIDUE IN THE RIGHT EYE (OD) WITH IRRIGATION. IT WAS A MANUALLY PERFORMED SURGERY, NO TREATMENT WITH VISUMAX. THE 3RD SURGERY ON PATIENT RIGHT EYE (OD) WAS A CIRCLE PROCEDURE (B)(6) 2025. IT WAS ABOUT LIFTING OF THE FLAP OD, NO RESIDUE WAS IDENTIFIED, AND REPOSITIONING OF THE FLAP. THE 4TH SURGERY - A TOPOSMOOTH ON RIGHT EYE (B)(6) 2025 - WAS PERFORMED WITH AN EXCIMER LASER ABLATION AND CLOSED WITH PLACEMENT OF A BANDAGE CONTACT LENS. ON (B)(6) 2026, THE PATIENT STILL COMPLAINS ABOUT BLURRY VISION WITH A SENSATION OF HAZE. THERE IS A SERIOUS INJURY ON A PATIENT RIGHT EYE (OD) REPORTED. ON THE FIRST SURGERY, THE LENTICULE WAS TORN DURING THE REMOVAL PROCEDURE AND THE PATIENT HAS SUFFERED THREE ADDITIONAL MEDICAL INTERVENTIONS (SURGERIES). THIS EVENT TOOK PLACE IN FRANCE.