A sample was not received at the manufacturing site for evaluation.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The photo attached to the parent file was reviewed by the manufacturing site.The photo show a broken piece of ophthalmic tip inside wrench.Reported issue cannot be confirmed from photo.A sample was not received at the manufacturing site and no lot information was provided; 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 adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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