BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICROINCISION IOL

    MDR report key: 6695566 · Received July 7, 2017

    Report

    Report Number
    0001313525-2017-02670
    Event Type
    Injury
    Date Received
    July 7, 2017
    Report Date
    June 9, 2017
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L FOR EVALUATION. THE LENS EVALUATION WAS PERFORMED USING OPTICAL MICROSCOPY, SCAN ELECTRON MICROSCOPE, AND ENERGY DISPERSIVE SPECTROSCOPY (SEM/EDS), TRANSMISSION ELECTRON MICROSCOPY (TEM), AND A SLIT LAMP. NO DISTINCT SURFACE ARTIFACTS, HAZE OR OPACIFICATION COULD BE CLEARLY OBSERVED EXCEPT UNDER SLIT LAMP LIGHTING CONDITION WHERE A FAINT, SPOTTY HAZE CAN BE SEEN. ELEMENTAL (EDS) ANALYSIS OF THE LENS SURFACE DETECTED CARBON (C), OXYGEN (O), AND NITROGEN (N). THE POSSIBILITY OF SURFACE CALCIFICATION WAS RULED OUT BY THE SEM/EDS AND TEM ANALYSIS RESULTS. THE CAUSE OF THE FAINT HAZE REMAINS UNDETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: REPORTEDLY, PATIENT HAD CORRECTABLE VISUAL ACUITY (VA) TO 20/20 BUT COMPLAINED OF EXTREME GLARE, AND MEASURED AT 20/200 WITH A BRIGHTNESS ACUITY TEST (BAT) PRIOR TO LENS IMPLANT TO THE LEFT EYE. THE PATIENT WANTED TO AVOID ANISOMETROPIA AND REMAIN MYOPIC SO PATIENT UNDERWENT UNCOMPLICATED SURGERY WITH A REFRACTIVE TARGET OF -2.50 TO MATCH THE RIGHT EYE. REPORTEDLY, PATIENT ALSO SAW A RETINA SPECIALIST WHO CONFIRMED THAT THERE WAS NO CHANGE IN THE RETINAL STATUS COMPARED TO PRE-OP EXAM AND OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING, AND THE OPTIC NERVE APPEARED NORMAL. REPORTEDLY, THE LENS LOOKED NORMAL, BUT GIVEN THE LACK OF OTHER FINDINGS AND THE SUDDEN CHANGE CORRESPONDING TO SURGERY, THE SURGEON ELECTED TO DO LENS EXCHANGE. SINCE THE LENS EXCHANGE PATIENT'S VISION HAS DECREASED AGAIN, FLUCTUATING BETWEEN 20/200 AND 20/60 (BSCVA) WITHOUT ANY PATHOLOGY ON ANTERIOR OR POSTERIOR SEGMENT EXAMS. PATIENT THOUGHT HIS VISION WAS SLIGHTLY BETTER FOLLOWING THE LENS EXCHANGE, BUT THE SURGEON COULDN'T BE CERTAIN THERE WAS ANYTHING WRONG WITH THE LENS. ACCORDING TO THE SURGEON, PATIENT'S VISION CHANGE IS STILL A MYSTERY AND THE SURGEON ENDED UP REFERRING HIM FOR POSSIBLE ELECTRORETINOGRAPHY (ERG) TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS DEVELOPED CENTRAL CLOUDINESS AND WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472952 AKREOS MICROINCISION IOL INTRAOCULAR LENS HQL BAUSCH + LOMB MI60 1740802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other