A surgeon reported that a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure and laser treatment.Upon post-operative examination of the patient, the surgeon noted 3+ aqueous cell, less than 1+ conjunctival inflammation, less than 1+ vitreous inflammation and aqueous fibrin.No cultures were performed and no intervention treatment was provided.The patient's symptoms have resolved without any additional treatment.This report represents the first of three patients for this surgeon.
|
No sample has been returned for evaluation; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.All the procedure paks are single-use devices provided to the customer in a sterile manner.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.All the procedure paks are single-use devices 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).
|