MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS BEING LOADED, A CRACK WAS OBSERVED IN THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. BASED ON ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT DURING AN IOL IMPLANTATION PROCEDURE, WHEN THE IOL WAS BEING ADVANCED INTO THE BAG, THE TOP OF THE CARTRIDGE SPLIT. THERE WAS NO IMPACT TO THE IOL. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A NEW CARTRIDGE. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

ONE COMPANY (D) CARTRIDGE WAS RETURNED IN THE OPENED POUCH. VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE NOZZLE WAS CRACKED TOP CENTER. THIS SPLIT AS IT ENTERED THE THINNER TIP. HEAVY STRESS WAS ALSO OBSERVED. THE COMPANY (D) CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOPCOAT 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 HANDPIECE AND VISCOELASTIC WERE INDICATED. THE LENS DIOPTER WAS NOT PROVIDED. IT IS UNKNOWN IF THE LENS WAS IN THE QUALIFIED DIOPTER RANGE. THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. IT IS UNKNOWN IF THE LENS WAS IN THE QUALIFIED DIOPTER RANGE. THE COMPANY (D) CARTRIDGE WAS RETURNED. THE NOZZLE WAS CRACKED TOP CENTER. THIS SPLIT AS IT ENTERED THE THINNER TIP. HEAVY STRESS WAS ALSO OBSERVED. 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 INSTRUCTIONS FOR USE (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. 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 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. 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). TOPCOAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. 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.