BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11778340 · Received May 5, 2021

    Report

    Report Number
    9612169-2021-00111
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    October 14, 2020
    Report Date
    August 18, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394819
    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 PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL OBSERVATIONS WERE IDENTIFIED AS 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 INTO THE MID NOZZLE AND THE PLUNGER IS ADVANCED UNDER THE LENS. THE TRAILING HAPTIC IS ADVANCED UNDER THE LENS. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT ""INJECTOR RIDING OVER THE IOL". PLUNGER UNDERRIDE OBSERVED. PLUNGER UNDERRIDE MAY OCCUR: ¿ IF THE LENS HAS BECOME MISALIGNED IN THE LENS BAY DURING THE MANUFACTURING PROCESS. ¿ 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 UNDERRIDE 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. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE.

    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 REPRESENTATIVE REPORTED THAT THEY EXPERIENCED ISSUES WITH THE INJECTORS RIDING OVER THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671404 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21259384 00380652394819

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC| PROVISC OPHTHALMIC