BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM

    MDR report key: 7975329 · Received October 17, 2018

    Report

    Report Number
    1119421-2018-01492
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LENS WERE RETURNED SEPARATED. INADEQUATE VISCOELASTIC IS OBSERVED IN THE DEVICE. THE PLUNGER IS ORIENTED CORRECTLY AND FULLY ADVANCED. THE LENS WAS UNDAMAGED AND RETURNED IN A SPECIMEN CUP. NO DAMAGE WAS OBSERVED TO THE DEVICE OR THE LENS. THERE WAS NO WHITE SEDIMENT OBSERVED. ONLY DRIED VISCOELASTIC IN THE DEVICE. A DIMENSIONAL INSPECTION (PLAN VIEW) WAS CONDUCTED OF THE LENS. THE LENS WAS WITHIN THE SPECIFICATION PER THE APPROVED TEMPLATE. THE NOZZLE WAS REMOVED AND CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THERE WAS NO DAMAGED OR MISSING INNER COATING OBSERVED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE ROOT CAUSE FOR THE REPORTED ¿DIFFICULT FOR SURGEON TO PUSH THE BUTTON TO INJECT¿ MAY BE RELATED TO A FAILURE TO FOLLOW THE DFU. A NON-QUALIFIED VISCOELASTIC WAS USED. MATERIAL PROPERTIES OF A NON-QUALIFIED VISCOELASTIC MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE TRAILING HAPTIC, LACK OF LUBRICITY OR OTHER UNPREDICTABLE OUTCOMES. INADEQUATE VISCOELASTIC WAS ALSO OBSERVED. 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 OR DELIVERY ISSUES. NO DAMAGE WAS OBSERVED TO THE LENS OR DEVICE. A DIMENSIONAL INSPECTION (PLAN VIEW) WAS CONDUCTED. THE LENS WAS WITHIN THE SPECIFICATION PER THE APPROVED TEMPLATE. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. IT IS POSSIBLE THAT THE REPORTED 'WHITE SEDIMENT' WAS DRIED VISCOELASTIC. THERE WAS NO WHITE SEDIMENT OBSERVED. ONLY DRIED VISCOELASTIC. THERE ARE NO OTHER COMPLAINTS IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE "BUTTON"ON THE INJECTOR WAS VERY DIFFICULT TO PUSH. ULTIMATELY, THE LENS WENT OUT WITH A WHITE SEDIMENT. THE SURGEON DID NOT PLACE THIS LENS, BUT USED A BACK UP LENS INSTEAD. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816859 ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LTD. - HUNTINGTON SN6CWS 12338094

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR