This subject was implanted with the argus ii device on (b)(6) 2008 as part of a clinical trial of the argus ii.In (b)(6) 2013, one week following a prior surgery on his implanted eye, the surgeon observed conjunctival dehiscence over the suture tab in an area where the surgeon had earlier observed thinned conjunctiva.He hypothesized that the movement of the conjunctiva during the prior surgery and the post-operative recovery caused the conjunctiva to dehisce.On (b)(6) 2013 the surgeon re-operated to trim the suture tab and close the conjunctiva under topical anesthesia.On week later ((b)(6) 2013), the surgeon observed that the conjunctiva had re-dehisced.On (b)(6) 2013, the surgeon cut off the suture tab and re-sutured the conjunctiva.On (b)(6) 2013, he determined this event was fully resolved.The device remains implanted and the subject will continue routine follow-up.There was no defect or malfunction of the device associated with this event.
|