MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

THE USED COMPANY CARTRIDGE WAS RETURNED WITH THE OPENED POUCH. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE TIP WAS NOT SPLIT. THE CARTRIDGE TIP HAD A LARGE ANEURYSM ON THE LEFT SIDE. THE TIP HAD HEAVY STRESS. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE USED COMPANY CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE USED COMPANY CARTRIDGE WAS RETURNED. THE TIP WAS NOT SPLIT. THE CARTRIDGE TIP HAD A LARGE ANEURYSM ON THE LEFT SIDE. THE TIP HAD HEAVY STRESS. THE ROOT CAUSE FOR THE OBSERVED DAMAGE APPEARS TO BE RELATED TO A FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE (IFU). INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE TIP ANEURYSM WOULD INDICATE THE LENS AND PLUNGER WERE NOT IN ACCEPTABLE POSITIONS FOR ADVANCEMENT. STRESS IS AN EXPECTED OCCURRENCE WITH A LENS DELIVERY AND DOES NOT DENOTE A PRODUCT DEFICIENCY. HOWEVER, IT CAN BE MORE PRONOUNCED IF THERE IS AN INADEQUATE AMOUNT OF VISCOELASTIC BETWEEN THE LENS AND THE CARTRIDGE LUMEN OR IF THE LENS IS NOT POSITIONED CORRECTLY. IN ADDITION, IF THE HANDPIECE PLUNGER IS NOT POSITIONED AT THE TRAILING OPTIC EDGE IT CAN ALLOW THE LENS TO FOLD AROUND THE PLUNGER TIP MAKING IT TOO LARGE TO CORRECTLY ADVANCE THROUGH THE NARROW TIP OF THE CARTRIDGE, WHICH COULD CAUSE DAMAGE TO THE TIP OR THE LENS. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE IFU INSTRUCTS: THE COMPANY IOL DELIVERY SYSTEM IS FOR IMPLANTATION OF QUALIFIED COMPANY FOLDABLE IOLS. NO UNQUALIFIED LENSES SHOULD BE USED WITH THE COMPANY IOL DELIVERY SYSTEM. THE COMPANY CARTRIDGES ARE QUALIFIED FOR USE WITH COMPATIBLE COMPANY HANDPIECES FOR THE SURGICAL IMPLANTATION OF COMPANY QUALIFIED FOLDABLE IOLS. COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT COMPANY. VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY ½ TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE CARTRIDGE GOT CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.