Description of Event or Problem · 1
IN 2012 AND 2013, I HAD SURGERY TO MY EYES TO REMOVE CATARACTS. MY SURGEON PLACED THE ALCON MULTI-FOCAL IOL LENS IMPLANTS IN MY EYES. IN 2019, MY VISION BECAME DISTORTED DUE TO THE DEFECTIVE ALCON IOL IMPLANTS. IN 2019 MY SURGEON, (DR. (B)(6)) REMOVED THE DEFECTIVE ALCON MULTI-FOCAL LENS AND REPLACED BOTH LENS WITH BAUSCH & LOMB. ALCON DEFECTIVE L LENS WERE PLACED IN MY EYES ON (B)(6) 2012 AND (B)(6) 2013. IN (B)(6) 2019, MY VISION BECAME DISTORTED. DR. (B)(6) TOOK PICTURES OF THE LENS IN MY EYES. THE LENS WERE NOT CLEAR AS THEY SHOULD HAVE BEEN. THEY LOOKED LIKE A SHAKEN UP SNOW GLOBE. DR. (B)(6) REMOVED THE DEFECTIVE MULTIFOCAL LENS IN (B)(6) 2019 AND REPLACED THE DEFECTIVE MULTIFOCAL LENS WITH BAUSCH & LOMB INTRAOCULAR LENS. DR. (B)(6) SENT THE DEFECTIVE LENSES BACK TO ALCON. DR. (B)(6) HAS PICTURES OF THE DEFECTIVE LENS. THE DEFECTIVE ALCON LENS WERE LEFT EYE - MODEL SN6AD1, SN (B)(4) AND RIGHT EYE - MODEL SN6AD1, SN (B)(4). I CONTACTED ALCON IN 2019 AND AS OF THIS DATE, THEY ARE SAYING "WE ARE INVESTIGATING THE ISSUE". ON THE FDA WEBSITE THERE IS A CLASS 1 DEVICE RECALL FOR RESTOR IOL, INTRAOCULAR LENS, PRODUCT CODE HQL AND THE MODEL NUMBER OF THE DEFECTIVE LENS REMOVED FROM MY EYES (MODEL SN6AD1) IS LISTED ON THE RECALL EVENT ID 71630. HOWEVER, THIS RECALL STATES THE LENSES SUBJECT TO THIS CORRECTION ARE MANUFACTURED SPECIFICALLY FOR (B)(6). THE DEFECTIVE ALCON MULTI-FOCAL LENS WERE REMOVED AND REPLACED WITH BAUSCH & LOMB INTRAOCULAR LENS. I HAD TO UNDERGO TWO ADD'L EYE SURGERIES AND NOW I HAVE TO WEAR TWO SEPARATE PAIR OF GLASSES (ONE FOR DISTANCE AND ONE FOR READING).