A nurse reported to a company representative that the tip sleeves they have received in the past eight to twelve months were difficult to insert through the incision, maneuver within the anterior chamber, and broke easily during an unknown number of cataract procedures.The tip sleeves were replaced and the procedures were completed.There was no indication of harm to the patients.Additional information was requested; however, none has been received to date.This is one of two reports for this facility.
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As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.A sample was not returned for this complaint report; visual inspection or functional testing could not be conducted in order to establish a potential failure mode for the device.The root cause of the customer's complaint could not be established as a sample has not been received.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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.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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