A patient reported that following a routine cataract surgery in the left eye, overwhelming pain was experienced that evening of surgery.The next morning, he went to the doctor and a technician measured his intraocular pressure and it was 51mmhg, the pupil was dilated and unresponsive.A second procedure was scheduled for the following day.Since his surgery four months ago, he has had two corneal transplants and retinal surgery.Additional information has been requested.
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Additional information provided.The patient male patient was scheduled originally for a cataract extraction with intraocular lens implant (iol) on the left eye (os).It has not been determined if the original surgery involved a retinal element, as the patient and surgeon have not provided this information.Additionally, the patient¿s medical and ocular histories were not provided.The patient left the surgical facility and was in pain.The first day post-operative examination revealed that the iop in the os was 51 mmhg.Per the patients¿ report, the technician confirmed the pupil was ¿unresponsive¿ at that time of the examination.The patient has confirmed that two (2) corneal transplant surgeries and an additional retinal surgery were required.The patient attributes the additional surgeries to the iop increase during the first cataract surgery.Additional, related information was requested from both the patient and the surgeon without success.As no further information has been obtained for review, the reported issue cannot be determined conclusively.No service request (sr) was opened for this case.The system was manufactured on january 27, 2015.Based on qa assessment, the product met specifications at the time of release.The root cause is unable to be determined conclusively.The manufacturer internal reference number is: (b)(4).
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