BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 10122727 · Received June 5, 2020

    Report

    Report Number
    1119421-2020-00822
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 1, 2020
    Report Date
    June 29, 2020
    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
    HU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD WAS ORIGINALLY REPORTED FOR THE PATIENTS RIGHT (OD) EYE. NEW INFORMATION RECEIVED STATING THE SERIAL NUMBERS OF THE INTRAOCULAR LENS (IOL) IMPLANTS USED IN BOTH EYES. WE DO NOT KNOW WHICH SERIAL NUMBER BELONGS FOR THE LENS IN EACH EYE SO THE RECORDS HAVE BEEN RENAMED FIRST EYE AND SECOND EYE. THIS RECORD WITH THE NEWLY ADDED SERIAL NUMBER IS FOR THE FIRST EYE OF THE PATIENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT SURGERY FOR AN INTRAOCULAR LENS (IOL) IMPLANT TWO (2) AND A HALF YEARS AGO IN BOTH EYES. AFTER THE SURGERY, THE PATIENT HAS DEVELOPED POSITIVE / NEGATIVE DYSPHOTOPSIA. HALF A YEAR AFTER SURGERY, A SECONDARY CATARACT DEVELOPED, SO A LASER CAPSULECTOMY WAS PERFORMED ON BOTH EYES. SINCE THEN, HIS LEFT EYE HAS BEEN SAID TO REFRACT LIGHT AS IF IT WERE ILLUMINATED WITH A LASER, AND IN HIS RIGHT EYE THERE HAS BEEN A FLOATING SPOT / PIECE OF TISSUE THAT MOVES IN THE EXACT OPPOSITE DIRECTION TO THE NATURALLY FLOATING SPOTS AND IS TERRIBLY CONFUSING. DURING THE LAST EXAMINATION, DR. (B)(6) ESTABLISHED THAT THE PATIENT VISION WAS 100%, BUT HE REALLY DOESN'T FEEL THAT WAY. UNDER NORMAL LIGHTING CONDITIONS, HE CAN SEE NEAR AND FAR, HOWEVER, HE CAN'T SEE WELL AT AN INTERMEDIATE DISTANCE (ALTHOUGH IF THE INCORRECT LENS HAS BEEN IMPLANTED, IT MAY BE BECAUSE OF IT), OR IN POORER LIGHT CONDITIONS, THE IMAGE IS OUT OF FOCUS AT DUSK AND IN THE DARK, THE VISION IS VERY POOR. DRIVING IN THE DARK BECAME DANGEROUS FOR HIM. IN BRIGHT LIGHT, IT LOOKS LIKE HE SEES AN AURA. HE DOES NOT DISPUTE THE QUALITY OF THE LENS ITSELF, HE SAYS HE CHOSE THE BEST ON THE MARKET, BUT UNFORTUNATELY HIS QUALITY OF LIFE HAS DETERIORATED SIGNIFICANTLY AFTER THE SURGERY. THIS RECORD IS FOR THE RIGHT EYE OF THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586427 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 12386962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention