MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

THE USED COMPANY CARTRIDGE WAS RETURNED. VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. NO DAMAGE WAS OBSERVED. THE CARTRIDGE HAD 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 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 LENS EDGE DAMAGE COULD NOT BE DETERMINED. THE LENS WAS NOT RETURNED FOR EVALUATION. EDGE DAMAGE MAY OCCUR IF THERE IS A PLUNGER OVER/UNDERRIDE. NO PROBLEM WAS FOUND WITH THE RETURNED COMPANY CARTRIDGE. NO DAMAGE OR ABNORMALITIES WERE OBSERVED. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE IFU (INSTRUCTIONS FOR USE) 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 (OPHTHALMIC VISCOSURGICAL DEVICE)-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 THE MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL (INTRAOCULAR LENS) 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. 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. 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)(6) 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 FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE EDGE OF THE LENS APPEARED MARRED. THE DEVICE MADE CONTACT WITH THE PATIENT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.