A physician reported multiple incidences of the capsular bag being aspirated and getting stuck in the irrigation/aspiration tip during the cataract surgeries.The physician pressed and release the reflux, though the reflux action never occurred, the capsules would gradually release or the physician used a second instrument to help release the capsules.There was no patients harm reported.
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Additional information provided in h.6.And h.10.The lot complaint history and dhr were not reviewed as no lot information was available for this complaint.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.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.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.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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