Description of Event or Problem · 0
I AM SUBMITTING THIS REPORT REGARDING SERIOUS AND ONGOING COMPLICATIONS FOLLOWING A SMILE (SMALL INCISION LENTICULE EXTRACTION) VISION CORRECTION PROCEDURE. THE SURGERY WAS PERFORMED ON (B)(6) 2023, IN THE UNITED STATES BY A LICENSED OPHTHALMOLOGIST. I PREFER NOT TO DISCLOSE THE CLINIC NAME AT THIS TIME. PRIOR TO THE PROCEDURE, I TRUSTED THE PROVIDER'S RECOMMENDATION AND WAS SEEKING SAFE VISION CORRECTION. HOWEVER, I NOW BELIEVE THAT I WAS NOT ADEQUATELY INFORMED ABOUT THE SEVERITY, LIKELIHOOD, AND POTENTIAL PERMANENCE OF THE RISKS ASSOCIATED WITH THIS PROCEDURE. FOLLOWING THE SURGERY, I DEVELOPED MULTIPLE SIGNIFICANT AND PERSISTENT COMPLICATIONS, INCLUDING: CORNEAL ECTASIA (A PROGRESSIVE WEAKENING AND DEFORMATION OF THE CORNEA), CHRONIC DRY EYE SYMPTOMS. SEVERE VISUAL DISTURBANCES, INCLUDING HALOS, GLARE, STARBURSTS, AND REDUCED NIGHT VISION, VISUAL SNOW AND CONSTANT VISUAL NOISE, FLUCTUATING AND REDUCED VISUAL ACUITY. EYE DISCOMFORT AND LIGHT SENSITIVITY. THESE COMPLICATIONS HAVE NOT RESOLVED AND HAVE PERSISTED FOR AN EXTENDED PERIOD OF TIME SINCE THE SURGERY. AS A RESULT OF THE PROCEDURE, I NOW REQUIRE ADDITIONAL MEDICAL INTERVENTIONS, INCLUDING CORNEAL CROSS-LINKING TO STABILIZE THE CORNEA AND THE USE OF SCLERAL LENSES TO ACHIEVE FUNCTIONAL VISION. MY CONDITION HAS SIGNIFICANTLY IMPACTED MY QUALITY OF LIFE. I EXPERIENCE DIFFICULTY PERFORMING DAILY ACTIVITIES SUCH AS WORKING ON A COMPUTER, READING WORKING UP CLOSE OR SEEING AT NIGHT AND MAINTAINING VISUAL STABILITY. THESE COMPLICATIONS HAVE ALSO CAUSED EMOTIONAL DISTRESS, ANXIETY, AND A DECLINE IN MY OVERALL WELL-BEING. I AM PARTICULARLY CONCERNED ABOUT THE INFORMED CONSENT PROCESS. THE RISKS OF SEVERE COMPLICATIONS SUCH AS CORNEAL ECTASIA AND LONG-TERM VISUAL DISTURBANCES WERE NOT CLEARLY OR ADEQUATELY DISCLOSED. I WAS NOT PROPERLY WARNED ABOUT THE POSSIBILITY OF PERMANENT OR PROGRESSIVE DAMAGE. SINCE THE PROCEDURE, I HAVE SOUGHT MEDICAL CARE; HOWEVER, THE AVAILABLE TREATMENTS ARE LIMITED AND DO NOT FULLY RESTORE MY VISION OR REVERSE THE DAMAGE. I AM SUBMITTING THIS REPORT TO RAISE SERIOUS CONCERNS ABOUT THE SAFETY OF SMILE PROCEDURES AND THE ADEQUACY OF PATIENT EDUCATION AND INFORMED CONSENT. PATIENTS SHOULD BE CLEARLY INFORMED ABOUT ALL POTENTIAL RISKS, INCLUDING RARE BUT LIFE-ALTERING COMPLICATIONS, BEFORE UNDERGOING THIS SURGERY. THANK YOU FOR YOUR ATTENTION TO THIS MATTER.