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Patient 0
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMITIES OR DEVIATIONS NOTED DURING THE MANUFACTURING OF THE LENS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE NATURE OF THIS COMPLAINT. ADDITIONALLY, OUR LENSES ARE 100% INSPECTED BEFORE THEY LEAVE OUR MANUFACTURING SITE. THEREFORE, WE ARE CONFIDENT THAT THE LENS WAS PROCESSED PER STANDARD OPERATING PROCEDURES AND INSPECTIONS AND HAVE MET ALL CRITERIA FOR RELEASE. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA 3-PIECE PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE FOLLOWING FACTOR MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE: OFF-LABEL USE OF THE YAMANE TECHNIQUE: THE CT LUCIA 602 LENS IS NOT VALIDATED FOR USE WITH THE YAMANE SCLERAL FIXATION TECHNIQUE. THIS OFF-LABEL METHOD INTRODUCES ROTATIONAL FORCES AND ANCHORING DYNAMICS THAT ARE NOT ACCOUNTED FOR IN THE DESIGN SPECIFICATIONS OF THE LENS. IN THIS CASE, THE SURGEON REPORTED THE HAPTIC WAS DAMAGED DURING LASERING AT THE OPTIC-HAPTIC JUNCTION, WHICH ULTIMATELY REQUIRED EXPLANTATION. THE HAPTICS, WHILE IDEAL FOR TRADITIONAL IN-THE-BAG IMPLANTATION, MAY NOT PROVIDE THE NECESSARY RESISTANCE OR STABILITY WHEN FIXATED EXTERNALLY VIA THE YAMANE TECHNIQUE. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS, AND NO PRODUCT-RELATED DEFICIENCY WAS IDENTIFIED. THE REPORTED FAILURE IS ATTRIBUTABLE TO OFF-LABEL HANDLING, NOT A PRODUCT MALFUNCTION.