MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) PROCEDURE, LENS WAS CAUGHT IN CARTRIDGE WHEN ADVANCING CARTRIDGE CRACKED. THE SURGERY WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN D.1., D.9., H.3., H.6. AND H.11. THE USED COMPANY III (D) CARTRIDGE WAS RETURNED. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE HAD AN ANEURYSM ON THE TOP, WHICH STARTED IN THE NOZZLE AND PROGRESSED INTO THE TIP. THE TIP ALSO HAD A LARGE ANEURYSM ON THE RIGHT SIDE. THE CARTRIDGE TIP ALSO HAD HEAVY STRESS. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE USED COMPANY III (D) CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOPCOAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE LENS WAS NOT RETURNED; HOWEVER, A PHOTO WAS PROVIDED THAT SHOWED THE CLEAR LENS ON AN ORANGE PIECE OF LINED PAPER. THE PHOTO WAS BLURRY. THE LENS WAS POSTERIOR SURFACE UP. A SMALL AMOUNT OF VISCOELASTIC APPEARED TO BE PRESENT. THERE APPEARED TO BE A HORIZONTAL CRACK ACROSS THE OPTIC. THIS DAMAGE WOULD INDICATE THE OPTIC EDGE WAS FOLDED OVER OR A PLUNGER OVER/UNDERRIDE OCCURRED. THE CLARITY OF THE PHOTO DOES NOT ALLOW FOR ANY FURTHER DETERMINATION. THE REPORTED COMPANY 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 COMPLAINT WAS MOST LIKELY RELATED TO A FAILURE TO FOLLOW THE IFU. THE COMPANY III (D) CARTRIDGE WAS RETURNED. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE HAD AN ANEURYSM ON THE TOP, WHICH STARTED IN THE NOZZLE AND PROGRESSED INTO THE TIP. THE TIP ALSO HAD A LARGE ANEURYSM ON THE RIGHT SIDE. THE CARTRIDGE TIP ALSO HAD HEAVY STRESS. THIS DAMAGE WOULD INDICATE THE LENS/PLUNGER WERE NOT IN ACCEPTABLE POSITIONS FOR ADVANCEMENT. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A PHOTO WAS PROVIDED OF THE LENS. THERE APPEARED TO BE A HORIZONTAL CRACK ACROSS THE OPTIC. THIS DAMAGE WOULD INDICATE THE OPTIC EDGE WAS FOLDED OVER OR A PLUNGER OVER/UNDERRIDE OCCURRED. 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. THE IFU INSTRUCTS: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL TO STAY IN THE FOLDED CONDITION. FAILURE TO ADHERE TO MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL DAMAGE. IFU NOTE: DURING LENS LOADING AND INSERTION, DO NOT ALLOW THE COMPANY IOL TO REMAIN IN A FOLDED CONDITION WITHIN THE SELECTED IOL DELIVERY SYSTEM FOR MORE THAN 3 MINUTES PRIOR TO COMPLETING INSERTION INTO THE CAPSULAR BAG. 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).