BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 8125378 · Received December 3, 2018

    Report

    Report Number
    1119421-2018-01683
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Report Date
    February 11, 2019
    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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WITH THE LENS WAS RETURNED LOOSE IN THE CARTON. THE PLUNGER LOCK AND LENS STOP HAVE BEEN REMOVED. THE PLUNGER IS ORIENTED CORRECTLY. VISCOELASTIC IS OBSERVED DRIED IN THE DEVICE. THE PLUNGER HAS ADVANCED TO MID-NOZZLE AND HAS OVERRODE THE OPTIC AT THE NOZZLE ENTRY AREA. THE TRAILING HAPTIC IS FOLDED ONTO THE OPTIC ALONG THE LEFT SIDE OF THE PLUNGER. THE PLUNGER OVERRIDE MAY HAVE BEEN INTERPRETED AS THE REPORTED COMPLAINT. THE NOZZLE WAS CLEANED FOR FURTHER EVALUATION. THE LENS WAS REMOVED DURING CLEANING. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. VISCOELASTIC WAS NOT PROVIDED. IT IS UNKNOWN IF A QUALIFIED PRODUCT WAS USED. A PLUNGER OVERRIDE WAS OBSERVED UPON RETURN, WHICH MAY HAVE BEEN INTERPRETED AS THE REPORTED COMPLAINT. THE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. MATERIAL PROPERTIES OF NON-QUALIFIED OVDS MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. PLUNGER OVERRIDE MAY OCCUR: DUE TO RAPID ADVANCEMENT FASTER THAN THE DFU RECOMMEND RATE. DUE TO THE USE OF A NON-QUALIFIED VISCOELASTIC. MATERIAL PROPERTIES OF NON-QUALIFIED OVDS MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. IF INADEQUATE VISCOELASTIC IS PLACED IN THE DEVICE THIS WILL CAUSE INADEQUATE COVERAGE OF THE LENS FOLD PATH WHICH MAY CAUSE THE LENS TO ADVANCE INCORRECTLY OR BECOME ¿STUCK¿ IN THE DEVICE ALLOWING THE PLUNGER TO OVERRIDE THE LENS. IF THE DEVICE IS OVERFILLED WITH OVD, THIS CAN PREVENT THE TRAILING HAPTIC FROM BEING PLACED PROPERLY OR MOVE THE LENS OUT OF POSITION RESULTING IN MISFOLDING. IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (> 23°C / 73° F) LENS FOLDING CONSISTENCY IS NEGATIVELY AFFECTED, THE LENS IS MORE ADHERENT AND THIS MAY INHIBIT LENS ADVANCEMENT. ANY OF THE ABOVE LISTED CAUSES ALONE, OR IN COMBINATION, MAY CREATE THE REPORTED EVENT. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FAULTY INTRAOCULAR LENS (IOL) IN A PRELOADED DELIVERY SYSTEM. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964545 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LTD. - HUNTINGTON AU00T0 12577647

    Patients

    Seq Age Sex Outcome Treatment
    1