LASIK SMILE VISUMAX FEMTOSECOND LASER

Description of Event or Problem

THE PATIENT SUBMITTED A VOLUNTARY REPORT TO THE FDA (MW5186394) STATING THAT THEY ARE HAVING SERIOUS AND ONGOING PROBLEMS AFTER A SMILE (SMALL INCISION LENTICULE EXTRACTION) EYE SURGERY. THE SURGERY WAS DONE ON (B)(6) 2023, IN (B)(6). AFTER THE SURGERY, THE PATIENT STATES TO HAVE DEVELOPED SEVERAL SERIOUS AND LONG-LASTING COMPLICATIONS, INCLUDING CORNEAL ECTASIA (A PROGRESSIVE WEAKENING AND CHANGE IN THE SHAPE OF THE CORNEA), CHRONIC DRY EYE, AND SEVERE VISION PROBLEMS. THESE VISION PROBLEMS INCLUDE HALOS, GLARE, STARBURSTS, POOR NIGHT VISION, VISUAL SNOW, AND CONSTANT VISUAL NOISE, AS WELL AS FLUCTUATING AND REDUCED CLARITY OF VISION. THE PATIENT ALSO EXPERIENCED ONGOING EYE DISCOMFORT AND SENSITIVITY TO LIGHT. THESE ISSUES HAVE NOT IMPROVED AND HAVE PERSISTED SINCE THE SURGERY. AS A RESULT, THE PATIENT REQUIRES ADDITIONAL MEDICAL TREATMENTS, INCLUDING CORNEAL CROSS-LINKING TO STABILIZE THEIR CORNEA AND THE USE OF SCLERAL CONTACT LENSES TO ACHIEVE FUNCTIONAL VISION. THE PATIENTS' CONDITION HAS AFFECTED THEIR QUALITY OF LIFE. THE PATIENT STRUGGLES WITH DAILY ACTIVITIES SUCH AS USING A COMPUTER, READING, DOING CLOSE-UP WORK, SEEING AT NIGHT, AND MAINTAINING CLEAR AND STABLE VISION. THESE COMPLICATIONS HAVE ALSO CAUSED EMOTIONAL DISTRESS, ANXIETY, AND A DECLINE IN THEIR OVERALL WELL-BEING. SINCE THE PROCEDURE, THE PATIENT STATES TO HAVE SOUGHT MEDICAL CARE, BUT THE AVAILABLE TREATMENTS ARE LIMITED AND DO NOT FULLY RESTORE VISION OR REVERSE THE DAMAGE. THE PATIENT HAS CONFIRMED THAT THERE ARE NO PLANS FOR A SECOND SURGERY.

Additional Manufacturer Narrative

FOLLOW UP WITH CONTACT LISTED IN MW5186394. CONFIRMED ON MAY 11, 2026 THAT THE EVENT TOOK PLACE IN (B)(6) AND NOT IN THE UNITED STATES. HOWEVER, CUSTOMER SITE INFORMATION AND DEVICE INFORMATION COULD NOT BE OBTAINED.