MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED COMPANY 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 MEETS THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF A QUALIFIED LENS MODEL AND HANDPIECE WITH A NON-QUALIFIED VISCOELASTIC. THE ROOT CAUSE OF THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU (INSTRUCTION FOR USE). THE VISCOELASTIC INDICATED IS NOT QUALIFIED FOR THE LENS/COMPANY COMBINATION USED. THE IFU INSTRUCTS THAT A COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE ACCOUNT INDICATED THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. 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 VISCO SURGICAL 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 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-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AT THE TIME OF LOADING, RESISTANCE WAS ENCOUNTERED WHILE THE LENS WAS IN THE CARTRIDGE AND THE HAPTIC WAS TORN. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND STATED IN THE SURGEON OPINION, THE LENS AND CARTRIDGE CONTRIBUTED TO CAUSE THE EVENT.