Description of Event or Problem · 1
MULTIFOCAL LENSES WERE IMPLANTED BILATERALLY FOLLOWING CATARACT SURGERIES ON (B)(6) 2012 ON (B)(6) 2013 I REPORTED THAT MY VISION FELT AS THOUGH I STILL HAD ASTIGMATISM. ON (B)(6) 2012 I REPORTED BLURRED VISION ESPECIALLY OF THE LEFT EYE, AND EXTREME LIGHT SENSITIVITY. ON (B)(6) 2012 I HAD YAG CAPSULOTOMY PROCEDURES THAT AFFORDED SOME RELIEF FROM LIGHT SENSITIVITY. ON (B)(6) 2012 I INQUIRED ABOUT LENS EXPLANTATIONS - WAS SEEN IN CONSULTATION REGARDING THIS ON (B)(6) 2013 BUT RISKS ARE INCREASED BY TIME LAPSE SINCE IMPLANTATION AND ALSO BY CAPSULOTOMIES. AFTER A NUMBER OF WAVE SCANS IN (B)(6) 2014, I WAS ADVISED OF NEARSIGHTEDNESS AND ASTIGMATISM BILATERALLY. LASIK PROCEDURE TO LEFT EYE WITH LITTLE IF ANY IMPROVEMENT. ADVISED VISION CONCERNS I HAVE (CONTRAST SENSITIVITY AND LIGHT SENSITIVITY) ARE RELATED TO MULTIFOCAL LENSES. CONFIRMED BY VISIT TO (B)(6) IN (B)(6) 2014. I HAVE ATTACHED A 2007 REPORT ON REDUCED CONTRAST SENSITIVITY SO CERTAINLY THIS IS A KNOWN PROBLEM AS WELL AS FREQUENT (ONE PHYSICIAN TOLD ME 1 IN 5 RECIPIENTS HE SEES IN HIS PRACTICE HAVE PROBLEMS). I'VE READ FDA ONLY DOES INVESTIGATIONS IF THEY RECEIVE A NUMBER OF COMPLAINTS. I WOULD LIKE TO POINT OUT THAT FIRST OF ALL MOST PATIENTS WHO UNDERGO CATARACT SURGERY WITH IMPLANTED LENSES ARE ELDERLY; MANY ELDERLY DO NOT HAVE COMPUTER ACCESS AND EVEN IF THEY DO, WHO KNOWS HOW TO FIND THE REPORTING FORMS? I ONLY ACCIDENTALLY CAME UPON THIS INFORMATION.