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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CARTRIDGE HAD CRACKED WITH A LENS. THERE WAS NO PATIENT HARM. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE CARTRIDGE WAS CRACKED FROM THE MIDDLE EXTENDING ALL THE WAY TO THE TIP ON THE TOP SIDE. THERE WAS NO IMPACT TO THE IOL. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY.

Additional Manufacturer Narrative

CORRECTION IN H.8. ADDITIONAL INFORMATION PROVIDED H.3., H.6., H.11 THE USED COMPANY SPECIFIC CARTRIDGE WAS RETURNED IN THE OPENED POUCH. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE NOZZLE WAS CRACKED TOP CENTER. THE TIP WAS SPLIT WITH A PARTIAL ANEURYSM. 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. A QUALIFIED VISCOELASTIC WAS INDICATED. THE LENS MODEL/DIOPTER AND HANDPIECE USED WERE NOT PROVIDED. IT CANNOT BE DETERMINED IF QUALIFIED PRODUCTS WERE USED. THE ROOT CAUSE OF THE REPORTED DAMAGE MAY BE RELATED TO A FAILURE TO FOLLOW THE INSTRUCTION FOR USE (IFU). INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE LENS MODEL/DIOPTER AND HANDPIECE USED WERE NOT PROVIDED. IT CANNOT BE DETERMINED IF QUALIFIED PRODUCTS WERE USED. EACH MODEL IS QUALIFIED FOR A SPECIFIC DIOPTER RANGE. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE INTRAOCULAR LENS (IOL) AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE CARTRIDGE NOZZLE WAS CRACKED TOP CENTER. THE TIP WAS SPLIT WITH A PARTIAL ANEURYSM. THE DAMAGE ON THE TOP OF THE NOZZLE STARTED IN THE THICK WALL CONE AREA. UNUSUALLY HIGH INTERNAL FORCES WOULD BE NEEDED TO CREATE DAMAGE IN THIS AREA. THE TWO DISTINCT AREAS OF DAMAGE WOULD INDICATE A PROGRESSIVE CHANGE THAT OCCURRED AS THE LENS WAS ADVANCED. DAMAGE IN THE THICK CONE WALL SECTION HAS BEEN ASSOCIATED WITH THE USE OF COLD VISCOELASTIC. THE IFU INSTRUCTS TO USE VISCOELASTIC, WHICH HAS BEEN ALLOWED TO COME TO THE OPERATING ROOM TEMPERATURE. THIS TYPE OF DAMAGE MAY ALSO OCCUR IF THE LENS/PLUNGER ARE NOT POSITIONED CORRECTLY FOR ADVANCEMENT. USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE (OPHTHALMIC VISCOSURGICAL DEVICE) 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 THE 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.