BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM

    MDR report key: 9596929 · Received January 16, 2020

    Report

    Report Number
    9612169-2020-00017
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 14, 2019
    Report Date
    April 6, 2020
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED IN THE BLISTER TRAY. THE LENS STOP HAS BEEN REMOVED. THE PLUNGER IS ORIENTED CORRECTLY. THE CORRECT NOZZLE CONFIRMED ON THE DEVICE. INSUFFICIENT AMOUNT OF OVD OBSERVED IN THE DEVICE - NO OVD PAST THE LENS. THE PLUNGER AND THE LENS ARE ADVANCED AT THE WOUND GUARD. THE PLUNGER IS AT THE TRAILING OPTIC EDGE - THE CORRECT POSITION. THE LEADING HAPTIC IS EXTENDED STRAIGHT. TRAILING HAPTIC IS NOT FULLY FOLDED ONTO THE OPTIC ¿ THE TIP OF THE HAPTIC IS FOLDED ONTO THE TRAILING OPTIC EDGE BUT THE REMAINING HAPTIC LEG IS LOOPED BACK. THE ROOT CAUSE MAY BE RELATED TO FAILURE TO FOLLOW THE DFU. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE DEVICE. THE DFU INSTRUCTS: FILL THE DEVICE UNTIL OVD CAN BE OBSERVED FLOWING TO THE ''FILL-TO'' LINE ON THE NOZZLE TIP. THIS WILL REQUIRE APPROXIMATELY 0.2 ML OF VISCOELASTIC. 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 UNDERRIDE THE LENS. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE IN A PRELOADED DEVICE. THE TIMING OF THE EVENT AND PATIENT IMPACT ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING EITHER THE IOL WAS MISSED BY THE INJECTOR, USUALLY MOVING ABOVE OR BELOW THE IOL. THE OTHER ISSUE BEING CITED WITH THE STIFFNESS OF THE INJECTOR. THE CUSTOMER IS NOT SURE WHICH PROBLEM WENT WITH WHAT DEVICE. THIS IS ONE OF FOUR REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62404 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21245284

    Patients

    Seq Age Sex Outcome Treatment
    1