BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL

    MDR report key: 10079344 · Received May 21, 2020

    Report

    Report Number
    1119421-2020-00789
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    March 13, 2020
    Report Date
    June 26, 2020
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10., H.3., H.6., AND H.10. ONLY HALF OF THE LENS WAS FOUND IN THE LENS CASE. VISCOELASTIC IS DRIED ON THE LENS. THE LENS WAS CLEANED WITH LPHSE. THE LENS HAS BEEN CUT ACROSS THE CENTER TYPICAL OF A REMOVAL. SCRATCHES ARE OBSERVED ACROSS THE CENTER PORTION. CRACKS ARE ALSO OBSERVED. THE DAMAGE OBSERVED HAS THE APPEARANCE OF DAMAGE CAUSED BY AN INSTRUMENT USED TO GRASP THE LENS. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCT WERE INDICATED. THE REPORTED DAMAGE WAS OBSERVED. THE DAMAGE OBSERVED HAS THE APPEARANCE OF DAMAGE CAUSED BY AN INSTRUMENT USED TO GRASP THE LENS. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET ALCON¿S RELEASE CRITERIA. BASED ON OUR OBSERVATION, AND THE REVIEW OF MANUFACTURING RECORDS, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. 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. (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTICED A DEFECT IN THE CENTER OF THE LENS. THE LENS WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED AFTER IMPLANTING A NEW LENS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541622 ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFAT40 12732141

    Patients

    Seq Age Sex Outcome Treatment
    1 MONARCH III D CARTRIDGE.| MONARCH III IOL HANDPIECE.| UNSPECIFIED PROVISC.