BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 3000806 · Received March 12, 2013

    Report

    Report Number
    2183946-2013-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K961242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CARTRIDGE CASE AND 3 CARTRIDGES WERE RECEIVED FOR INSPECTION. CARTRIDGES APPEAR USED WITH FRAYED EDGES, STRESS MARKS AND ALSO APPEARS TO HAVE EVIDENCE OF VISCOELASTIC. FURTHER INVESTIGATION INDICATED THAT WHEN EXAMINING THESE TWO INJECTORS, IT WAS NOTICED THAT THE TIPS OF THE RODS WERE NOT CENTERED JUST BEFORE THEY EXIT THE ANODIZED PORTION OF THE INJECTOR. IT SEEMED AS THOUGH EXCESSIVE FORCE WAS APPLIED TO THE ROD AT SOME POINT. IT IS BELIEVED THAT THIS EXCESSIVE FORCE COULD BE APPLIED TO THE ROD DURING THE NORMAL, TYPICAL USE OF THIS PART. IF THE TIPS ARE NOT CENTERED AS THEY EXIT THE INSERTERS, IT WOULD CAUSE THE CARTRIDGES TO GET STUCK AS THEY EXITED THE INJECTOR - EXACTLY AS REPORTED. A SIGNIFICANT AMOUNT OF DRAG IS FELT WHEN SCREWING THE RODS IN AND OUT OF THE INJECTORS. BEFORE EACH INJECTOR IS SHIPPED, OPERATORS VERIFY THAT THE ROD FALLS FREELY IN AND OUT OF THE INJECTORS AT LEAST THE DISTANCE COVERED BY THE NORMAL ONE-DIRECTIONAL THREADS ON THE RODS. BOTH THESE INJECTORS DO NOT PASS THIS TEST AS IS. THE PRODUCT WARRANTY SPECIFIES A WARRANTY PERIOD OF TWENTY-FOUR (24) MONTHS AND BOTH PIECES ARE OUT OF WARRANTY. ALL INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (B)(6) 2013. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: AR40E LENS AND EMERALDC30 UNFOLDER CARTRIDGE, LOT NO. CK01712. (B)(6). (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR LOADED AN INTRAOCULAR LENS, MODEL AR40E INTO THE CARTRIDGE AND THEN INTO THE UNFOLDER HANDPIECE. WHEN THE DOCTOR TRIED TO DEPLOY THE LENS, THE INSERTION BAR WOULD NOT MOVE FORWARD. AS THE DOCTOR TRIED HARDER, THE BAR ''JUMPED AND SCRATCHED THE LENS''. THIS DIFFICULTY WAS OBSERVED WITH TWO (2) DIFFERENT INSERTERS AND A NUMBER OF LENSES AND CARTRIDGES. THE PROBLEM WAS EVENTUALLY SOLVED BY THE NURSE PRESSING DOWN VERY FIRMLY ON THE LOADED CARTRIDGE. THE BAR THEN SLID THROUGH AND THE FOURTH LENS EVENTUALLY DEPLOYED. THERE WAS NO PATIENT INJURY REPORTED; THE DIFFICULTY OCCURRED PRE INSERTION OF THE LENS. MEDICATION WAS PRESCRIBED POST IOL, DEXTAMETHASONE, AS A PRECAUTION FOR THE EXTENDED OPERATION TIME. THE DOCTOR, REPORTEDLY IS A VERY EXPERIENCED IMPLANTER AND VERY FAMILIAR WITH ABBOTT MEDICAL OPTICS (AMO) PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103711 EMERALD SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS EMERALDAR 4-030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention