BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 19321509 · Received May 15, 2024

    Report

    Report Number
    1119421-2024-00941
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 11, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652395069
    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

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ONLY THE DEVICE WAS RETURNED. THE LENS WAS NOT RETURNED. THE PLUNGER LOCK AND LENS STOP HAVE BEEN REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS OBSERVED IN THE DEVICE. THE PLUNGER WAS RETRACTED TO MID-NOZZLE. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED BECAUSE THE LENS WAS NOT RETURNED "STUCK IN THE CARTRIDGE" AS DESCRIBED. THE LENS WAS NOT RETURNED FOR EVALUATION. ONLY THE ULTRASERT DEVICE WAS RETURNED. THE ROOT CAUSE FOR THE REPORTED EVENT MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. A NON-QUALIFIED VISCOELASTIC WAS USED IN THE DEVICE. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE ACRYSOF¿ IQ IOL WITH THE ULTRASERT¿ PRELOADED DELIVERY SYSTEM, A 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: 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 DEGREE C / 73 DEGREE 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. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUEST FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H.3., H.6., AND H.11. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. A NON-QUALIFIED VISCOELASTIC WAS USED IN THE DEVICE. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE LENS WITH PRELOADED DELIVERY SYSTEM, A 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 DEGREE C / 73 DEGREE 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. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUEST FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, THEY NOTICED THAT NON COMPANY VISCOELASTIC WAS USED IN THE CARTRIDGE BUT WHEN THE SURGEON CAME TO USE IT SHE TOLD THAT THE LENS GOT STUCK IN THE CARTRIDGE. NO HARM CAME TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519159 ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON ACU0T0 15652118 00380652395069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OPHTEIS.