MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

ONE USED COMPANY III (D) CARTRIDGE WAS RETURNED. THE USED COMPANY III (D) CARTRIDGE WAS RETURNED IN A PLASTIC BAG WITH THE PATIENT'S NAME AND OD. THE USED COMPANY III (D) CARTRIDGE WAS MICROSCOPICALLY EVALUATED. VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE TIP HAD A LARGE ANEURYSM ON THE LEFT SIDE AND HEAVY STRESS. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE USED COMPANY III (D) CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE TEN UNOPENED MONARCH III (D) CARTRIDGES WERE OPENED FOR EVALUATION. THE COMPANY III (D) CARTRIDGES WERE MICROSCOPICALLY EXAMINED WITH NO DAMAGE OBSERVED OR ABNORMALITIES OBSERVED. THE TEN COMPANY III (D) CARTRIDGES WERE FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE (IFU). NO LENS OR CARTRIDGE DAMAGE WAS OBSERVED AFTER THE LENS DELIVERIES. THE COMPANY III (D) CARTRIDGES WERE CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A PHOTO WAS PROVIDED. THE PHOTO WAS OF AN IMPLANTED SINGLE-PIECE LENS. A SCRAPE MARK WAS OBSERVED, WHICH APPEARED TO BE ON THE POSTERIOR SURFACE OF THE LENS. THIS DAMAGE WAS SIMILAR IN APPEARANCE TO DAMAGE CAUSED BY A PLUNGER UNDERRIDE. 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. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE ROOT CAUSE FOR THE REPORTED LENS DAMAGE COULD NOT BE DETERMINED. THE LENS REMAINS IMPLANTED. THE USED COMPANY III (D) CARTRIDGE TIP HAD A LARGE ANEURYSM AND HEAVY STRESS. THIS DAMAGE WOULD INDICATE THE LENS/PLUNGER WERE NOT IN ACCEPTABLE POSITIONS FOR ADVANCEMENT. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A PHOTO WAS PROVIDED WHICH SHOWED A SCAPE MARK, WHICH APPEARED TO BE ON THE POSTERIOR SURFACE OF THE LENS. THIS DAMAGE WAS SIMILAR IN APPEARANCE TO DAMAGE CAUSED BY A PLUNGER UNDERRIDE. TEN SAMPLES WERE RANDOMLY SELECTED FOR EVALUATION FROM THE RETURNED UNOPENED COMPANY III (D) CARTRIDGES FOR THE REPORTED LOT. FUNCTIONAL AND DYE STAIN TESTING WAS CONDUCTED WITH THE UNOPENED SAMPLES WITH ACCEPTABLE RESULTS. NO LENS OR CARTRIDGE DAMAGE WAS OBSERVED AFTER THE LENS DELIVERIES. 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. 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 MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL 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 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 PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.