MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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.

Description of Event or Problem

A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE EYE WITH THE INJECTOR SET AS USUAL, AND THE IOL WAS CONFIRMED TO BE DAMAGED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN 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 EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE COMPANY III (D) CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A VIDEO WAS PROVIDED. THE CATARACT REMOVAL WAS SHOWN. THIS TOOK 5:00 MINUTES. THE CARTRIDGE PREPARATION AND LENS LOADING WERE NOT SHOWN. THE CARTRIDGE TIP CAME INTO VIEW AT 5:03 MINUTES FROM THE BOTTOM RIGHT OF THE SCREEN. THE YELLOW LENS MODEL WAS VISIBLE ADVANCED TO THE FILL LINE. THE PLUNGER WAS OVER THE TRAILING OPTIC EDGE. THE TRAILING OPTIC WAS FOLDED AROUND THE PLUNGER TIP. THE OPTIC WAS CRACKED ON THE EDGE AND ON THE LEFT AND RIGHT SIDE WHERE THE PLUNGER OVERRODE THE LENS. FOLD LINES WERE ALSO OBSERVED, WHICH MAY INDICATE THE LENS WAS LOADED FOR AN EXTENDED PERIOD OF TIME. FOLD LINES MAY ALSO OCCUR WHEN THE LENS IS ADVANCED TOO RAPIDLY, WHEN THE OR/ROOM TEMPERATURE IS TOO COLD, OR IF INADEQUATE VISCOELASTIC WAS PLACED IN THE DEVICE. THE VIDEO ENDED WITH THE LENS STILL IN THE EYE. 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 DAMAGE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. NO PROBLEM WAS FOUND WITH THE RETURNED COMPANY III (D) CARTRIDGE. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. BASED ON REVIEW OF THE PROVIDED VIDEO, THE PLUNGER WAS OVER THE TRAILING OPTIC EDGE. THE TRAILING OPTIC WAS FOLDED AROUND THE PLUNGER TIP. THE OPTIC WAS CRACKED ON THE EDGE AND ON THE LEFT AND RIGHT SIDE WHERE THE PLUNGER OVERRODE THE LENS. FOLD LINES WERE ALSO OBSERVED, WHICH MAY INDICATE THE LENS WAS LOADED FOR AN EXTENDED PERIOD OF TIME. FOLD LINES MAY ALSO OCCUR WHEN THE LENS IS ADVANCED TOO RAPIDLY, WHEN THE OR/ROOM TEMPERATURE IS TOO COLD, OR IF INADEQUATE VISCOELASTIC WAS PLACED IN THE DEVICE. 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.