A surgeon reported that one day following ocular surgery, a patient presented with pain which was relieved after a leak from the eye.Two days after, a reaction started in the anterior chamber, patient presented with pain and low vision which evolved into endophthalmitis.The patient underwent a vitrectomy.The patient is reported to have "hand motion" visual acuity and macula fibrosis.The patient will require an additional procedure.Additional information has been requested.
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There are multiple factors that could contribute to the occurrence of endophthalmitis.A patient¿s ocular flora or microorganisms that have colonized the surface structures (eyelids and conjunctiva) are the usual cause of infection, therefore isolating eyelids and eyelashes from the surgical field is crucial.The most common cultured microorganisms are gram-positive coagulase negative cocci (70%) with staphylococcus epidermis (s.Epidermis) the most prevalent.Deoxyribonucleic acid (dna) analyses of s.Epidermis strongly suggest that it is likely that commensal bacterial contaminating the anterior chamber at the time of surgery are responsible for most cases of endophthalmitis.Meticulous prepping and draping of the patient before surgery are important as well, to isolate the eyelids and lashes from the surgical field.Finally, attempts should be made to decrease any postoperative patient risk factors, such as immunosuppression or systemic disorders that may affect the wound healing and the ability of the eye to ward off any inoculums of bacteria during cataract surgery.Intraoperative risk factors may be associated with an increased incidence of postoperative endophthalmitis.These include inadequate disinfection of the eyelid or conjunctiva, vitreous loss, or unplanned/unapparent ocular penetration.The cataract console is a closed system.It is operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phaco handpiece is a reusable device that must be reprocessed per the product dfu.The system operator¿s manual includes a warning: ensure that appropriate system parameters and system settings are selected prior to starting the procedure.There is no evidence that the design or performance of the system caused or contributed to this reported event of endophthalmitis.The system was manufactured on may 5, 2015.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events were not able to be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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