A nurse reported that a patient experienced toxic anterior segment syndrome (tass).Procedure details and patient impact have not been provided.Additional information has been requested.Additional information received indicated that after a cataract surgery, the patient experienced tass in the right eye.The patient had no surgical complications.The patient presented post-operatively with no signs of symptoms.Upon examination of the patient, the surgeon noted 4+ aqueous cell.The patient was prescribed with post-operative antibiotic and steroid eye drops.No cultures were performed.The patient's outcome was unknown.This file represent the first patient of three from this facility.
|
No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The customer did not retain the product lot information for this custom pak, therefore the device history records (dhr) traceable to the reported procedure pack could not be reviewed.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Custom pak and the components inside of the paks are single-use items provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|