BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6127743 · Received November 25, 2016

    Report

    Report Number
    1119421-2016-01645
    Event Type
    Injury
    Date Received
    November 25, 2016
    Report Date
    December 9, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT EXPERIENCED PAIN AND HEADACHES POSTOPERATIVELY.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING BLURRY VISION AFTER CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON STATING MEDICATIONS WERE ALTERED FOLLOWING THE PROCEDURE. APPROXIMATELY THREE MONTHS FOLLOWING THE IMPLANT, THE PATIENT REPORTED TO THE SURGEON THAT THE AFFECTED EYE "FEELS BETTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778231 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT6 12201556

    Patients

    Seq Age Sex Outcome Treatment
    1 Other