BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL

    MDR report key: 15447861 · Received September 19, 2022

    Report

    Report Number
    1119421-2022-01995
    Event Type
    Injury
    Date Received
    September 19, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT HAD TO HAVE YTTRIUM ALUMINUM GARNET (YAG). THE PATIENT HAD BEEN TOLD THAT NOT NEURO-ADAPTING TO THE LENSES AS THE PATIENT COULD SEE CLOUDY ALL THE TIME. THE PATIENT WAS PRESCRIBED WITH PILOCARPINE THAT ASSISTED VISION BUT HAVING TO USE IT Q 2-3 HOURS. THE PATIENT HAD SEEN A RETINA SPECIALIST AND HE SUGGESTED TO HAVE LENSES CHANGED. THE PATIENT NIGHT VISION IS DESTROYED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT STARTED TO EXPERIENCE THE SYMPTOMS IMMEDIATELY AFTER THE IMPLANT PROCEDURE. THE PATIENT COULD NOT SEE CLEARLY, AFTER THE YAG PROCEDURE IT GOT BETTER BUT WITHIN A WEEK. HOWEVER BACK TO CLOUDINESS AND HALOS. THE PATIENT FURTHER DESCRIBED THAT IS LIKE I AM LOOKING THROUGH CELLOPHANE, WITH MORE CLOUDINESS IN PERIPHERAL VISION. LIGHTS AT NIGHT ESPECIALLY HAVE MULTIPLE RINGS AROUND THEM AND THEN A STARBURST OF THE LAST RING, LETTERS AND WORDS HAVE A SHADOW TO THEM. THE PATIENT PASSED THAT EVERY TEST THEY GIVE, THE PATIENT CAN MAKE THE LETTERS OUT IT JUST TAKES SOME CONCENTRATION. THE PHYSICIAN ALSO PROVIDE GLASSES BUT THEY DO NOT MAKE ANY DIFFERENCE SO HE TOLD ME NOT TO WEAR THEM. THE RETINA SPECIALIST ASSESSMENT WAS THAT THE PATIENT WAS NOT NEURO-ADAPTING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428702 ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFAT00 15328480

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other| R