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Patient 0
THE CUSTOMER STATED THAT THE DEVICE CANNOT BE RETURNED THEREFORE A PROPER ROOT CAUSE ANALYSIS COULD NOT BE COMPLETED NOR THE REPORTED ISSUE CONFIRMED. WITHOUT A PROPER DEVICE ANALYSIS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. REVIEWING THE MANUFACTURING DOCUMENTS DID SHOW NO INDICATIONS FOR A MALFUNCTION OF THE LENS. THE PRODUCT WAS PRODUCED IN ACCORDANCE TO MANUFACTURES SPECIFICATION AND NO DEVIATION HAS BEEN DETECTED. IT WAS STATED BY THE CUSTOMER THAT THEY ARE USING THE YAMANE TECHNIQUE TO IMPLANT THE LENSES. THIS TECHNIQUE INDUCES A LARGER AMOUNT OF FORCE WHILE TRYING TO POSITION THE HAPTICS IN THE SCLERAL TUNNEL. OUR LENSES ARE INTENDED TO BE IMPLANTED IN THE CAPSULAR BAG. THUS, THE LENS WAS BEING USED OFF-LABEL. THERE WAS NO DAMAGE REPORTED TO HAVE BEEN NOTICED DURING THE INSPECTION PRIOR TO USE AND PREPARATION, WHICH SUGGESTS A PRODUCT DEFICIENCY, DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA PRODUCT, AND BASED ON OUR EXPERIENCE WE HAVE DETERMINED THAT THE FOLLOWING FACTORS MAY HAVE CAUSE OR CONTRIBUTED TO THE REPORTED ISSUE IS BUT IS NOT LIMITED TO: LENS PLACEMENT TECHNIQUE , LOADING STRATEGY , ACCESSORY DEVICE SUPPORT , POOR HANDLING DURING FOLDING AND INSERTING.