BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11777974 · Received May 5, 2021

    Report

    Report Number
    9612169-2021-00110
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 24, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394826
    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

    CORRECTION: ON INITIAL MDR THE PRODUCT PROBLEM CODE OF 2339 WAS AN ERROR. IT SHOULD HAVE BEEN 4010 ON THE ORIGINAL MDR. CORRECTED AND ADDITIONAL INFORMATION WAS PROVIDED IN D.9, H.2, H.3, H.6, H.10, AND H.11. D.9 IS ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. ADDITIONAL OBSERVATIONS WERE IDENTIFIED AS THE DEVICE IS RETURNED LOOSE IN THE CARTON. THE LENS STOP AND THE PLUNGER STOP HAS BEEN REMOVED. THE CORRECT NOZZLE CONFIRMED ON THE DEVICE. VISCOELASTIC IS OBSERVED IN THE DEVICE. THE PLUNGER AND THE LENS ARE ADVANCED AT THE WOUND GUARD AND IS ADVANCED UNDER THE LENS. THE TRAILING HAPTIC IS ADVANCED UNDER THE LENS. THE LEADING HAPTIC IS EXTENDED STRAIGHT. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT "INJECTOR RIDING OVER THE IOL". PLUNGER UNDERRIDE OBSERVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. NO OTHER COMPLAINTS REPORTED IN THE LOT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED ABOUT PATIENTS WHO EXPERIENCED ISSUES WITH THE "INJECTORS RIDING OVER THE IOL ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672303 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21271111 00380652394826

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC