BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1033984 · Received April 24, 2008

    Report

    Report Number
    MW5006404
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    December 1, 2006
    Report Date
    April 24, 2008
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD NO IDEA I COULD COMPLAIN. I HAD CRYSTAL LENS SURGERY ON BOTH EYES. ON THE RIGHT EYE IT TOOK WELL. ON THE LEFT EYE I KEPT COMPLAINING TO THE DR ABOUT NOT SEEING WELL. AFTER ABOUT 6 MONTHS, HE DILATED MY EYES AND MY LEFT EYE WAS 20/50. BLIND ACCORDING TO THE STATE. I WAS REFERRED TO A RETINA SPECIALIST. DROPPED LIKE I HAD NEVER BEEN IN THEIR OFFICE BEFORE. I HEARD ABOUT A COMPLAINT TODAY ON T.V. AND DECIDED TO WRITE. ANYWAY, I WENT TO THE RETINAL SPECIALIST AND HE GAVE ME STEROID DROPS. IF THAT DID NOT WORK, I WOULD RETURN FOR SHOTS IN THE EYE. IF THAT DID NOT WORK, SURGERY. MY RETINA HAD A TEAR IN IT. I WENT TO MY PRIMARY CARE PHYSICIAN AND GOT A REFERRAL TO ANOTHER RETINA SPECIALIST. HE SAID THE SAME THING. AFTER ABOUT TWO WEEKS, I RETURNED AND THE RETINA CLEARED UP. I WILL TELL YOU I DID NOT USE THE EYE DROPS AND WON'T TELL YOU HOW IT GOT CLEAR. ON WITH THE STORY. I NOW HAVE TO WEAR GLASSES AND I STILL HAVE TROUBLE WITH MY EYE SIGHT. I DID NOT KNOW THAT IT WOULD BE SUCH AN ORDEAL. THEY DID NOT TELL ME THAT. ALSO, I KEPT GETTING BILLS. I CALLED AND THEY SAID THEY DO NOT LIST THE FACILITY USE AT THE DOCTOR'S OFFICE ON THE STATEMENT. SO I AM STILL PAYING. IF I HAD KNOWN I COULD WRITE A COMPLAINT I WOULD HAVE AT THE TIME. I HAVE ALL OF MY MEDICAL RECORDS AND I HAVE ALL THE DOCUMENTATION. I AM VERY DISAPPOINTED WITH THE SURGERY AND WOULD HAVE HAD JUST ONE EYE DONE IF I HAD KNOWN. I COULD HAVE HAD THE CATARACT REMOVED ON THE LEFT AND GONE WITH A POSSIBILITY OF IT GROWING BACK AGAIN FOR REMOVAL BECAUSE THE INSURANCE COMPANIES WILL NOT LET YOU GET THEM REMOVED UNTIL YOU ARE ALMOST BLIND. ANOTHER COMPLAINT. I WAS DRIVING 100 MILES A DAY TO AND FROM WORK WITH CATARACTS THAT BARELY LET ME SEE THE HIGHWAY, AND HOW SAFE IS THAT. WELL MY COMPLAINT IS NOW FILED. I HAVE TO WEAR GLASSES AND FEEL THAT IF I WAS INSTRUCTED CORRECTLY THIS WOULD NOT HAVE HAPPENED. I THOUGHT I WOULD GET OUT OF WEARING GLASSES, HAVE BETTER VISION AND NEVER HAVE CATARACTS AGAIN. WRONG. STILL PAYING ON TOP OF THAT. SO WHERE IS THE JUSTICE? GOOD THING I HAD INSURANCE OR I WOULD HAVE REALLY BEEN OUT ON MY OWN. PLUS THE FACT THAT IF MY RETINA DID NOT CLEAR UP I WOULD HAVE HAD TO HAVE SURGERY AGAIN ON THE EYE FOR REPAIR AND I WAS REALLY SCARED THAT I WOULD NEVER GET THE VISION BACK. SO DO WHAT YOU DO AND I THINK THAT PEOPLE SHOULD BE AWARE THAT EVEN DOCTORS WITH THE BEST CREDENTIALS MESS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CRYSTAL LENS HQL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention