No lot number was identified with this complaint; therefore, a lot history review could not be conducted.No phaco tip or particle sample were returned for evaluation; therefore, the condition of the product could not be verified.Because a product sample or particle were not returned from the customer and no lot information was provided for a lot record review, the root cause for customer complaint issue cannot be determined.Based on the complaint information, the phaco wrench may be the possible source for plastic particles.The manufacturer internal reference number is: (b)(4).
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