A healthcare professional reported the sleeves were not the same as they had different shades of color, the lighter ones were thinner, broke more easily when they were being placed in the phacoemulsification (phaco) needles, get curled especially when trying to enter the incision, and there was a significant reduction in infusion into the eyes.There was no patient harms reported.This is one of multiple reports for these reported events.
|
The customer did not retain the product lot information.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.It was reported by the customer, that there was variation in the infusion sleeve coloration.Although, no sample has yet been received.Review of a customer provided image, appears to show color variation between infusion sleeves.However, without analysis of the samples, we cannot conclusively determine, there is a non-conformance.The color criteria for this sleeve is evaluated, during inspection, and the color was determined, to be within the allowable acceptance criteria for this sleeve.The color variation should not impact the intended function of the sleeve.The product was not returned.And therefore, a root cause evaluation could not be performed.The root cause of the customer's complaint could not be determined conclusively, as the samples were unable to be evaluated.However, the source of the color variation would originate from the supplier's manufacturing process.This complaint has been reviewed.And the supplier has been made aware of this complaint issue.The supplier has been reviewing their process to ensure greater consistency in sleeve coloration.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).
|