A sample was not received at the manufacturing site for evaluation for the report of there was metallic foreign bodies retained in the patient eyes therefore, the condition of the product could not be verified.Even though no lot number was identified with this complaint, our products are processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and no lot information is available therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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