[319250]
In 2003 coopervision surgical's medical director received an e-mail from dr, a surgeon involved in co's programme during which five free devices were supplied for implantation with local investigation review board (irb) approval. One of these devices was implanted in the pt. In his e-mail, dr indicated that the patient had done well after alphacor, with more than 6 months of follow-up since stage ii surgery but that the patient, whom he stated had senile dementia, had presented for routine follow complaining of discomfort. Dr's description of the device situation on examination was not entirely clear. It was described as "over the corneal surface, under the conjunctiva, with a cloudy anterior chamber. " as the device is normally within the corneal surface with its optic centrally exposed and the periphery covered with tissue, it suggests that the device was in situ, as one would not expect a formed (cloudy or otherwise) anterior chamber if that were not so. It also suggests that a small melt of tissue adjacent to the conjunctiva, or device damage, had occurred so as to cause inflammation, possibly infection, within the anterior chamber. A sub-acute stromal melt could allow formation of tissue posterior to the device (a retroprosthetic membrane) sealing the anterior chamber while a device extruded, but this would prevent a view of the anterior chamber as reported. Another possibility is that the device had loosened following stromal melting but was kept in place by a constricted opening in the overlying conjunctiva. The patient was taken to theatre and a sub-acute endophthalmitis diagnosed clinically. Antibiotics were given and the device/surrounding tissue trephined away and replaced with a donor graft. At this stage the patient was reported to have no vision in the eye. The surgeon stated that he surmised that the patient had rubbed the eye to cause dislodgement of the device and consequent infection. Medical directorreplied to dr via email on the same day to express her concern and ask for more details, specifically whether there had been a melt of corneal tissue noted and whether there were any particular risk factors in this case related to medication, compliance or contact lens wear. She indicated that she and dr would discuss this case further when they meet in the us, as planned, during her forthcoming visit to the us, scheduled for early july 2004. Medical director also offered to collect the device for analysis. In his reply to this email, dr stated that there had been no other complicating factors, nor was this a case of stromal meltmg. He believed the patient had rubbed the eye severely enough to cause the complication, probably at night, and suggested that alphacor patients wear protective eye shields at night. Further follow-up by coopervision surgical occurred when its president met with dr as previously arranged, for a dinner discussion and dr stated during this meeting that he did not regard this case as a serious event for alphacor. Within coopervision surgical, the case was discussed at a regular weekly review meeting and a management review meeting, and all clinical support and management staff were informed of the event. At this stage the event was classed as a complication, pending the planned review of the case with dr and it was noted that in view of dr comments company would review the patient/surgeon information to see whether any additional advice was required, as well as updating co's clinical data and information for surgeons. In 2004, coopervision surgical was notified that the event had been reported to the fda's medwatch as an adverse event, using one of coopervisions surgical's forms available from its internet site, argusconnect. On this form, the event has been indicated as "secondary surgical intervention to remove the device and replace it with a second device or a donor tissue graft as a result of spontaneous disintegration or break-up of the device. " this appears to suggest a different history to the one reported to coopervision surgical. According to coopervision surgical's adverse event reporting criteria, if this eye has indeed permanently and totally lost vision as a result of alphacor, it qualifies as an adverse event under another of the stated definitions: "the device directly causes permanent and irreversible total loss of vision in an eye that was previously sighted. " however, one would have to state that, based on the patient history provided, it was not the device itself that caused loss of vision, but a complication that occurred some time after its implantation, the nature of which has not been clarified but could involve device damage secondary to rubbing of the eye by the patient. The medwatch form notes that the cause of the event was unknown and does not mention the eye rubbing reported to company.
Patient Sequence No: 1, Text Type: D, B5