MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A MARK ON THE IMPLANT. THERE WAS NO ISSUE OCCURRED DURING FOLDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; 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. ROOT CAUSE HAS NOT BEEN IDENTIFIED. A PHOTO WAS PROVIDED. THE PHOTOS SHOWED THE EYE OF THE PATIENT. A NARROW MARK WAS OBSERVED, WHICH APPEARED TO BE ON THE ANTERIOR SURFACE OF THE OPTIC. THE MARK STARTED AT THE EDGE AND TRAVELLED IN TOWARD THE CENTER. THE HAPTIC GUSSET AREAS WERE NOT VISIBLE; THE ORIENTATION OF THE MARK COULD NOT BE DETERMINED FROM THE PHOTO. DAMAGE TO THE ANTERIOR SURFACE MAY BE CAUSED BY FORCEPS OR A PLUNGER OVERRIDE. IF LOADED PROPERLY, THE ANTERIOR SURFACE DOES NOT CONTACT THE CARTRIDGE INNER LUMEN. 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

ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS REPORTED THAT PRIOR TO IMPLANTATION, THE INTRAOCULAR LENS HAD BEEN INSPECTED IN ACCORDANCE WITH STANDARD PROCEDURES, WITH NO DEFECTS OR ABNORMALITIES IDENTIFIED AT THAT STAGE. REGARDING THE PRESENCE OF A POTENTIAL SCRATCH AND ITS FUNCTIONAL IMPACT, POSTOPERATIVE FOLLOW-UP INDICATED NO SIGNIFICANT VISUAL DISCOMFORT, AND THE BEST-CORRECTED VISUAL ACUITY REMAINED STABLE AT 8/10. THE POSSIBLE SCRATCH WAS REPORTED NOT TO BE LOCATED IN THE VISUAL AXIS, OR IF PRESENT, IT DID NOT RESULT IN ANY NOTICEABLE FUNCTIONAL IMPAIRMENT. BASED ON THE AVAILABLE FINDINGS, NO CONFIRMED DEFECT OF THE IMPLANT WAS IDENTIFIED. A MALFUNCTION OF THE INJECTOR COULD NOT BE ENTIRELY RULED OUT; HOWEVER, NO CLINICAL EVIDENCE SUPPORTED THIS HYPOTHESIS. AS A PRECAUTIONARY MEASURE, THE INJECTOR IN QUESTION WAS CONSIDERED FOR WITHDRAWAL FROM STOCK. THE POSTOPERATIVE COURSE WAS REPORTED AS FAVORABLE, WITH STABLE CONDITION, UNCHANGED OCT (OPTICAL COHERENCE TOMOGRAPHY) FINDINGS, AND NORMAL INTRAOCULAR PRESSURE. ROUTINE FOLLOW-UP WAS TO CONTINUE AS PER STANDARD PROTOCOL. IN VIEW OF THE ABSENCE OF FUNCTIONAL COMPLAINTS AND CLINICAL STABILITY, NO EXPLANTATION WAS PLANNED. AS PER REPORTER NO FURTHER INFORMATION WAS EXPECTED FOR THIS REPORT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN B.5. H.3., AND H.11. THE COMPANY CARTRIDGE WAS NOT RETURNED. A PHOTO WAS PROVIDED. THE PHOTO SHOWED THE EYE OF THE PATIENT. A NARROW MARK WAS OBSERVED, WHICH APPEARED TO BE ON THE ANTERIOR SURFACE OF THE OPTIC. THE MARK STARTED AT THE EDGE AND TRAVELLED IN TOWARD THE CENTER. THE HAPTIC GUSSET AREAS WERE NOT VISIBLE; THE ORIENTATION OF THE MARK COULD NOT BE DETERMINED FROM THE PHOTO. DAMAGE TO THE ANTERIOR SURFACE MAY BE CAUSED BY FORCEPS OR A PLUNGER OVERRIDE. IF LOADED PROPERLY, THE ANTERIOR SURFACE DOES NOT CONTACT THE CARTRIDGE INNER LUMEN. 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 COMPANY CARTRIDGE WAS NOT RETURNED. THE LENS REMAINS IMPLANTED. A ROOT CAUSE CANNOT BE DETERMINED WITHOUT PHYSICAL EXAMINATION OF THE PRODUCT. THE PROVIDED PHOTO SHOWED THE PATIENT¿S EYE. A NARROW MARK WAS OBSERVED, WHICH APPEARED TO BE ON THE ANTERIOR SURFACE OF THE OPTIC. THE MARK STARTED AT THE EDGE AND TRAVELLED IN TOWARD THE CENTER. THE HAPTIC GUSSET AREAS WERE NOT VISIBLE; THE ORIENTATION OF THE MARK COULD NOT BE DETERMINED FROM THE PHOTO. DAMAGE TO THE ANTERIOR SURFACE MAY BE CAUSED BY FORCEPS OR A PLUNGER OVERRIDE. IF LOADED PROPERLY, THE ANTERIOR SURFACE DOES NOT CONTACT THE CARTRIDGE INNER LUMEN. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD) 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. 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. 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 HALF TURN TO ENGAGE THE THREADS AND THEN STOP. THE INTRAOCULAR LENS (IOL) WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. INFORMATION WAS PROVIDED FROM THE SURGEON THAT ONE-MONTH POSTOPERATIVE FOLLOW-UP REVEALED NO VISUAL ISSUES FOR THE PATIENT. BEST-CORRECTED VISUAL ACUITY WAS STABLE AT 8/10. THE FOLLOW-UP EXAMINATION SHOWED STABLE CONDITION WITH UNCHANGED OPTICAL COHERENCE TOMOGRAPHY (OCT) FINDINGS AND NORMAL INTRAOCULAR PRESSURE MEASURED AT 13 MILLIMETERS OF MERCURY (MMHG) IN THE RIGHT EYE. ROUTINE FOLLOW-UP WILL CONTINUE ACCORDING TO STANDARD PROTOCOL. GIVEN THE ABSENCE OF FUNCTIONAL COMPLAINTS AND CLINICAL STABILITY, NO EXPLANTATION IS CURRENTLY PLANNED. 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.