A nurse reported that they received a pack of substituted gauze received were open, which resulted in tiny strands getting on other things in the pak, because of which the gauze entered in patient's eye and surgeons had to bring the patients back for the procedure to remove the little gauze strands and particles which were ended in the patients eyes.The procedure and patient harm details were not reported.
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As the customer did not retain the finished goods lot number, dhr and lot history could not be reviewed.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If possible, the customer should provide alcon with a photo of the reported issue in order to help with the investigation of this complaint.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.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Based on current tracking, there are no adverse trends for this reported complaint.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).
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