MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED. 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. A QUALIFIED HANDPIECE AND VISCOELASTIC WERE INDICATED. THE LENS MODEL PROVIDED, THIS COMPANY MODEL LENS, IS NOT QUALIFIED FOR USE WITH THIS COMPANY MODEL CARTRIDGE. THE CORRECT CARTRIDGE IS INDICATED ON THE LENS CARTON AND LENS CASE LABELS. IT IS UNKNOWN IF OTHER LENS MODELS WERE ALSO USED. THE COMPANY CARTRIDGE WAS NOT RETURNED. THE ROOT CAUSE FOR THE REPORTED DAMAGE MAY BE RELATED TO A FAILURE TO FOLLOW THE (INSTRUCTIONS FOR USE) IFU. A QUALIFIED HANDPIECE AND VISCOELASTIC WERE INDICATED. THE LENS MODEL PROVIDED, COMPANY LENS, IS NOT QUALIFIED FOR USE WITH THE COMPANY CARTRIDGE. THE CORRECT CARTRIDGE IS INDICATED ON THE LENS CARTON AND LENS CASE LABELS. IT IS UNKNOWN IF OTHER LENS MODELS WERE ALSO USED. THE IFU INSTRUCTS: THE COMPANY CARTRIDGES ARE QUALIFIED FOR USE WITH COMPATIBLE COMPANY HANDPIECES FOR THE SURGICAL IMPLANTATION OF COMPANY QUALIFIED FOLDABLE IOLS. COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. SPLIT TIPS MAY OCCUR DUE TO: ¿ ROOM TEMPERATURE TOO COLD/COLD OVD ¿ PLUNGER ADVANCEMENT SPEED TOO FAST ¿ INADEQUATE OVD PLACED IN THE CARTRIDGE THE IFU INSTRUCTS TO USE THE COMPANY CARTRIDGE AT OPERATING ROOM TEMPERATURES BETWEEN 18° C (64° F) AND 23° C (73° F). THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD (THAT HAS BEEN ALLOWED TO COME TO ROOM TEMPERATURE) 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).

Description of Event or Problem

A NONHEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION CRACKING AND BREAKING. NEW CARTRIDGES WERE OPENED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENSES WERE HALFWAY IN THE EYE WHEN THE CARTRIDGES WERE CRACKING.

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).