MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE A SCUFF AFTER IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE IOL WAS EXPLANTED AND REPLACED. THE SURGEON ALSO STATED THAT THE LENS WAS SCUFFED POSSIBLY BY THE CARTRIDGE. THERE WAS NO IMPACT TO THE PATIENT.

Additional Manufacturer Narrative

THE USED COMPANY CARTRIDGE WAS RETURNED. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE TIP HAD A LARGE ANEURYSM ON THE LEFT SIDE. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE USED COMPANY CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOPCOAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE REPORTED PRODUCT LOT NUMBER WAS NOT PROVIDED. LOT SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES COULD NOT BE CONDUCTED. HOWEVER, BEFORE PRODUCTION RELEASE, EACH DEVICE HISTORY RECORD IS REVIEWED TO ENSURE THAT THE PRODUCT MET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE ROOT CAUSE FOR THE REPORTED LENS DAMAGE APPEARS TO BE RELATED TO A FAILURE TO FOLLOW INSTRUCTIONS FOR USE (IFU). INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE TIP HAD A LARGE ANEURYSM ON THE LEFT SIDE. THIS WOULD INDICATE THE LENS/PLUNGER WERE NOT IN ACCEPTABLE POSITIONS FOR ADVANCEMENT. THE LENS DAMAGE WAS ON THE ANTERIOR SURFACE. IF THE LENS IS LOADED PROPERLY THE ANTERIOR SURFACE DOES NOT CONTACT THE CARTRIDGE LUMEN. DAMAGE TO THE ANTERIOR SURFACE MAY BE CAUSED BY A PLUNGER OVERRIDE OF BY LOADING FORCEPS. THE LENS AND CARTRIDGE DAMAGE WOULD INDICATE A PLUNGER OVERRIDE OCCURRED. TOPCOAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. 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. THE IFU INSTRUCTS: 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. IMPORTANT: 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. THE HANDPIECE IFU INSTRUCTS: 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.