BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 14497138 · Received May 25, 2022

    Report

    Report Number
    1119421-2022-01127
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 22, 2022
    Report Date
    February 13, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652395182
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. FILE WILL BE REOPENED WHEN PRODUCT IS RECEIVED. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE DIRECTION FOR USE (DFU). A NON-QUALIFIED VISCOELASTIC WAS USED IN THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE COMPANY IOL WITH COMPANY PRELOADED DELIVERY SYSTEM, AN COMPANY QUALIFIED OPHTHALMIC VISCOELASTIC DEVICE (OVD) SHOULD BE USED. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE DEVICE PREPARATION AND IMPLANTATION STEPS. LENS MAY BECOME STUCK IN THE DEVICE: IF INADEQUATE VISCOELASTIC IS PLACED IN THE DEVICE THIS WILL CAUSE INADEQUATE COVERAGE OF THE LENS FOLD PATH WHICH MAY CAUSE THE LENS TO BECOME ¿STUCK¿ IN THE DEVICE. 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 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. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WITH THE LENS WAS RETURNED LOOSE IN A DRAWSTRING PLASTIC BAG. THE PLUNGER LOCK AND THE LENS STOP WERE REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS OBSERVED IN THE DEVICE. THE PLUNGER WAS ADVANCED TO MID-NOZZLE AND HAS UNDERRODE THE LENS. THE LENS WAS LOCATED AT MID-NOZZLE. THE OPTIC WAS MISFOLDED UP, ROTATED, AND TORN BY THE ADVANCING PLUNGER UNDERRIDE. THE LEADING HAPTIC WAS EXTENDED. THE TRAILING HAPTIC WAS MISFOLDED, LOOPED AROUND THE PLUNGER TIP AND ADVANCED UNDER THE OPTIC. THE DISTAL HAPTIC AREA OF THE TRAILING HAPTIC WAS EXTENDED BACKWARD ALONG THE RIGHT SIDE OF THE PLUNGER. THE NOZZLE WAS REMOVED AND CLEANED FOR FURTHER EVALUATION. THE LENS WAS REMOVED DURING CLEANING. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A PLUNGER UNDERRIDE WAS OBSERVED. OPTIC DAMAGE AND MISFOLDED TRAILING HAPTIC POSITION WAS ALSO OBSERVED. THE PLUNGER UNDERRIDE, MISFOLDED TRAILING HAPTIC AND OPTIC, AND THE DAMAGE TO THE TRAILING HAPTIC AND OPTIC WERE MOST LIKELY INTERPRETED AS THE REPORTED COMPLAINT OF ¿LENS STUCK¿. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE COMPANY PRELOADED DELIVERY SYSTEM, AN COMPANY QUALIFIED OPHTHALMIC VISCOELASTIC DEVICE (OVD) SHOULD BE USED. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE DEVICE PREPARATION AND IMPLANTATION STEPS. PLUNGER UNDERRIDE MAY OCCUR: DUE TO RAPID ADVANCEMENT FASTER THAN THE IFU 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 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A SERIES OF FAULTY LENS. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE LENS WAS STUCK IN THE INTRODUCER AND FAILED TO INJECT INTO THE EYE. THERE IS A PATIENT CONTACT INVOLVED. THE SURGERY WAS COMPLETED USING ANOTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755542 ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON ACU0T0 15301224 00380652395182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VISCOELASTIC: Z - HYALIN