Description of Event or Problem · 1
AFTER I HAD THE RAINDROP INLAY PROCEDURE I WAS ABLE TO SEE CLOSE UP FOR ABOUT 2 MONTHS. THEN MY CLOSE UP VISION STARTED TO GO BACK TO WHERE IT WAS PRIOR TO THE IMPLANT. SO NOW NOT ONLY DID THE PROCEDURE NOT WORK AND I HAVE RETURNED TO WEARING READING GLASSES, BUT MY DISTANCE VISION IN THAT EYE IS VERY POOR. ON MY MOST RECENT EYE EXAM I COULDN'T EVEN READ THE TOP LINE ON THE EYE CHART. PREVIOUSLY I NEVER HAD ANY PROBLEMS WITH DISTANCE VISION. I ALWAYS FEEL LIKE I HAVE SOMETHING IN MY EYE. I WOULD LIKE TO HAVE THIS REMOVED SINCE IT HAS NO BENEFIT TO ME. BUT I WANT TO BE SURE THAT I WILL REGAIN MY DISTANCE VISION IF I HAVE IT REMOVED. I HAVE NO ADVOCATE FOR GETTING THIS DONE. MY EYE SURGEON NEVER MENTIONED THE RECALL TO ME. I DON'T WANT TO DEVELOP THE CORNEAL HAZING THAT LED TO THIS RECALL. SO I REALLY DON'T KNOW WHERE TO TURN. I TRIED TO CONTACT THE COMPANY, THEY HAVE CHANGED THEIR NAME AND PHONE NUMBERS. MY DR REIMBURSED ME (B)(6), I PAID TO HAVE THIS DONE BECAUSE IT DIDN'T WORK. I DON'T THINK I SHOULD HAVE TO PAY TO HAVE A RECALLED MED DEVICE REMOVED FROM MY EYE. WAS HOPING FOR SOME ADVICE OR DIRECTION TO TURN TO THIS HELP. DISTANCE VISION LOSS. (B)(6), DON'T KNOW THE LOT NUMBER OF THE RAINDROP INLAY. FDA SAFETY REPORT ID # (B)(4).