BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11677637 · Received April 16, 2021

    Report

    Report Number
    9612169-2021-00087
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 7, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394758
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. (PRODUCT PROBLEMS CODE WAS UPDATED). THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. 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 IS ADVANCED INTO THE MID NOZZLE AND IS ADVANCED OVER THE LENS. THE LENS IS IN THE LENS BAY. THE TRAILING HAPTIC IS FOLDED ONTO THE OPTIC AND IS EXTENDED STRAIGHT ALONGSIDE THE PLUNGER. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT "PISTON PASSED THE IOL". PLUNGER OVERRIDE OBSERVED. PLUNGER OVERRIDE 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 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. 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 DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT PAST THE LENS WHEN TRYING TO IMPLANT IT. THE SURGEON EXCHANGED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576478 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21279583 00380652394758

    Patients

    Seq Age Sex Outcome Treatment
    1 DISCOVISC| DISCOVISC