BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR LENS

    MDR report key: 8843468 · Received July 29, 2019

    Report

    Report Number
    MW5088549
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    April 16, 2019
    Report Date
    July 29, 2019
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LENS IMPLANTED IN RIGHT EYE BY EYE SPECIALISTS OF (B)(6). PATIENT HAS STATED THAT HAS PROBLEMS SEEING CLOSE AND FAR, NIGHTTIME DRIVING, READING, BLURRED VISION, AND MIGRAINE HEADACHES DUE TO THE DISSIMILARITY OF THE EYES. HE WENT FOR A SECOND OPINION TO THE (B)(6) EYE CTR ON (B)(6) 2019. THE PATIENT SAW TWO DRS AND THEY SPENT 5 HOURS LOOKING AT PATIENT'S EYE AND TOLD HIM THAT IT'S A FAILED LENS, AND TOLD HIM THAT APPROX 9% OF LENS TYPICALLY FAIL AND THIS ONE SHOULD BE REMOVED AND REPLACED. THEY ALSO FOUND NO STRUCTURAL DEFECTS WITH THE PATIENT'S EYE THAT WOULD HAVE CAUSED THE FAILURE. THE PATIENT ALSO STATES THAT ALCON HAS BEEN ENCOURAGING HIM TO NAME A PRICE FOR A REFUND, YET THEY HAVE ALSO SAID THAT HE MAY NOT GET ANY MONEY AT ALL, AND IN ADDITION TO THAT THEY HAVE ALSO BEEN ASKING FOR THE PATIENT'S MEDICAL RECORDS. THE (B)(6) HAS ALSO INFORMED THE PATIENT THAT IF HE DOES NOT GET A RE-OPERATION SOON, HE CAN POTENTIALLY GO BLIND IN THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628762 ACRYSOF IQ RESTOR LENS INTRAOCULAR LENS HQL ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R| S