MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

THE USED COMPANY CARTRIDGE WAS RETURNED. INADEQUATE VISCOELASTIC WAS OBSERVED. THE CARTRIDGE HAD AN ANEURYSM, WHICH STARTED AT THE TOP OF THE NOZZLE. THE ANEURYSM TORE AS IT ENTERED THE THINNER TIP MATERIAL. HEAVY STRESS WAS ALSO OBSERVED. THE CARTRIDGE HAS 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. THE LENS WAS RETURNED IN THE LENS CASE. VISCOELASTIC WAS DRIED ON THE LENS. ONE HAPTIC WAS BROKEN-GUSSET AREA, NOT RETURNED. THE OPTIC WAS CRACKED AT THE HAPTIC/OPTIC JUNCTION OF THE BROKEN HAPTIC. THIS DAMAGE WOULD INDICATE A PLUNGER OVERRIDE OCCURRED. THE RETURNED PRODUCT MATCHED THE PROVIDED PHOTOS. 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 INSTRUCTIONS FOR USE (IFU). IF THE LENS IS LOADED PROPERLY THE HAPTICS ARE TUCKED IN THE OPTIC FOLD AND DO NOT CONTACT THE INNER LUMEN OF THE CARTRIDGE. BROKEN HAPTICS TYPICALLY OCCUR DUE TO MISLOADING OR A PLUNGER OVERRIDE. THE RETURNED COMPANY CARTRIDGE WAS DAMAGED. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE HAD AN ANEURYSM, WHICH STARED AT THE TOP OF THE NOZZLE JUST BEHIND THE PARTING LINE. THE ANEURYSM TORE AS IT ENTERED THE THINNER TIP. THIS DAMAGE WOULD INDICATE THE LENS/PLUNGER WERE NOT IN ACCEPTABLE POSITIONS FOR ADVANCEMENT. THE REPORTED BROKEN HAPTIC WAS OBSERVED. THE OPTIC WAS ALSO CRACKED AT THE HAPTIC/OPTIC JUNCTION. THIS WOULD INDICATE PLUNGER OVERRIDE OCCURRED. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH UNSPECIFIED VISCOELASTIC (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 HALF TURN TO ENGAGE THE THREADS AND THEN STOP. THE INTRAOCULAR LENS (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.

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CARTRIDGE HAD A DEFECT IN THE PLASTIC AND IT TORE THE HAPTIC OFF THE INTRAOCULAR LENS (IOL). IT WAS STATED THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION RECIEVED AND STATED THAT AFTER LOADING THE LENS AND WHILE PREPARING TO PLACE THE TIP OF THE CARTRIDGE INTO THE CHAMBER, THE SURGEON NOTICED A DISTORTION OF THE CARTRIDGE UNDER THE MICROSCOPE. A DECISION WAS MADE TO CHANGE THE CARTRIDGE, AND THE LENS WAS PUSHED THROUGH THE NOZZLE OF THE CARTRIDGE TO RETRIEVE IT. WHILE USING THE SCREW ON THE BACK OF THE INSERTION HANDPIECE, THE LENS WAS SCRATCHED AND THE HAPTIC ARM WAS TORN FREE FROM THE BODY OF THE LENS. IT WAS THEN NOTICED THAT THE CARTRIDGE WAS CRACKED AND/OR HAD AN EXTRANEOUS PIECE OF PLASTIC HANGING INTO THE PATH OF THE LENS .