Description of Event or Problem · 1
ON APPROX (B)(6) 2011, DR. (B)(6) IMPLANTED A FP7 AHMED IMPLANT INTO MY LEFT EYE BECAUSE OF HIGH PRESSURE (GLAUCOMA). AS A RESULT OF THE IMPLANT, THE PRESENT WENT LOWER, HOWEVER I'VE SUFFERED FROM CHRONIC EYE PAIN AND INFLAMMATION OVER THE IMPLANT SINCE THAT TIME, WHICH IS NOW 13 MONTHS. PRIOR TO THE VALVE IMPLANT, I DIDN'T HAVE SIGNIFICANT REDNESS (SCLERITIS/UVEITIS) LOCALIZED IN THE LEFT EYE DIRECTLY OVER THE IMPLANT. SPECIALISTS AT THREE DIFFERENT CLINICS RULED OUT UVEITIS/SCLERITIS. MY DOCTORS HAVE INCREASED THE AMOUNT OF DEXAMETHASONE EYE DROPS TO TRY TO REDUCE THE PAIN AND REDNESS, BUT BOTH PROBLEMS PERSISTED DESPITE TREATMENT WITH STEROID EYE DROPS. I'VE ATTEMPTED, PHONE CALLS TWICE TO GET MATERIAL SAFETY DATA SHEETS FROM THE MFR OF THE AHMED IMPLANT, (B)(6), HOWEVER, STAFF INFORMED ME THAT THERE ARE NO MSDS SHEETS FROM THE DEVICE. MY DOCTORS (B)(6) HAVE SENT EMAILS BUT NO ONE HAS RESPONDED FROM (B)(6). I'M SCHEDULED FOR ADD'L TESTS NEXT MONTH TO TRY TO DETERMINE IF I'M HAVING AN ALLERGIC REACTION TO ONE OR MORE OF THE MATERIALS IN THE FP7 AHMED IMPLANT, BUT WILL HAVE TO POSTPONE THE TESTS IF (B)(6) FAILS TO PROVIDED MY DOCTOR WITH THE REQUESTED MATERIALS. I BELIEVE THAT THE AHMED IMPLANT HAS CAUSED THE CHRONIC PAIN AND INFLAMMATION IN THE LEFT EYE BECAUSE THE INFLAMMATION WAS NOT EVIDENT PRIOR TO THE TRANSPLANT. I'M TRYING TO DETERMINE WHETHER THERE'S AN ALLERGY TO THE IMPLANT MATERIALS, BUT HAVE NOT SEEN ANYTHING IN THE LITERATURE OR FDA REPORTS SHOWING THAT THIS HAS HAPPENED BEFORE TO A PT OR BEEN REPORTED BEFORE.