Chapter 6: Additional Information
Page 90
During the study, 28 of the 30 subjects
experienced
at
least
one
side effect
or
complication related to the Argus II System or the
surgery to implant the device. Two subjects had
no side effects.
Of the 28 subjects, 17 had non-serious side
effects that either were treated with medication or
did not require any treatment at all. Six subjects
had one serious complication that was treated with
medication or a simple surgery (for example,
repairing a suture used to close the wound in the
eye).
Five
subjects
had
multiple
serious
complications, some of which were treated with
surgery. Of these last five subjects, four had a
“cascade” of events, meaning that one
complication led to another complication.
Serious Complications
Below is a list of the serious complications during
the study. Of the 30 subjects:
•
4 subjects had a decrease in the pressure
of the eye, making the eye soft
•
3 subjects had an opening of the surgical
wound where the eye tissue covers the
implant.
•
3 subjects had a portion of the implant wear
through the tissue that covers it, leaving
that part of the implant uncovered.
•
3 subjects had an infection in the eye
