It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye that the facility feels are coming from the back table cover.The facility reported that the event has occurred with eight patients.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, procedural, or retrieval details to the manufacturer.No sample has been received for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.This is report six of eight.
|