A surgeon reported the 2.4 millimeter pink sleeves do not remain in position as they enter the eye or it winkles which requires more twisting and maneuvering to get into the eye because the sleeves are flimsy during an unspecified number of cataract procedures.This occurred at least once a day (one out of seven procedures).In addition, he indicated that for several months, some sleeves remain at the wound at the time of inserting the phaco tip into the eye.This is one of two reports for this surgeon.
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The customer did not retain the product lot information, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.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.The manufacturer internal reference number is: (b)(4).
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