Product evaluation ¿ probe the customer reported that removing their laser probe detached the valved trocar from the sclera.The illuminated flex curved laser probe was received and a visual assessment of the returned sample was performed.It showed that the nitinol was loose, indicating that it is not properly bonded to the cannula.However, this is determined to be unrelated to the reported event.The sample was inserted into a 25 gauge trocar cannula and passed through with no noticeable resistance.The sample¿s outer cannula diameter was measured and found to meet specifications.It should be noted that the laser probes are visually inspected during manufacturing to verify the tips are conforming.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product.The product met specifications at the time of release.Product evaluation - 25g entry pak no sample has been returned for evaluation for the report of trocar detached from sclera during removal; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.All trocar are 100% inspected by the automated assembly machine for gauge size.Any non-conformances found are removed from the lot and scrapped.The root cause cannot be determined conclusively.The manufacture 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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