MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CARTRIDGES CRACKED ON IMPLANTATION. THE SURGERY WAS COMPLETED ON SAME DAY EITHER WITH A NEW CARTRIDGE OR JUST CONTINUED THROUGH CRACKED CARTRIDGE IF IOL WAS ALMOST OUT. THERE WAS NO DAMAGE TO THE LENS, IT REMAINS IMPLANTED. THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM.

Additional Manufacturer Narrative

THE USED COMPANY SPECIFIC CARTRIDGE WAS RETURNED WITH THE OPENED POUCH. 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 SPECIFIC 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 SPECIFIC 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 MAY BE RELATED TO A FAILURE TO FOLLOW THE INSTRUCTION OF USE (IFU). 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 SPECIFIC INTRAOCULAR LENS (IOL) DELIVERY SYSTEM IS FOR IMPLANTATION OF QUALIFIED COMPANY SPECIFIC FOLDABLE IOLS. NO UNQUALIFIED LENSES SHOULD BE USED WITH THE COMPANY SPECIFIC IOL DELIVERY SYSTEM. THE COMPANY SPECIFIC COMPANY SPECIFIC CARTRIDGES ARE QUALIFIED FOR USE WITH COMPATIBLE COMPANY SPECIFIC COMPANY SPECIFIC HANDPIECES FOR THE SURGICAL IMPLANTATION OF COMPANY SPECIFIC QUALIFIED FOLDABLE IOLS. COMPANY SPECIFIC FOLDABLE IOLS ARE QUALIFIED FOR USE WITH A COMPANY SPECIFIC QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO 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. 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.