BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4240953 · Received November 5, 2014

    Report

    Report Number
    1119421-2014-00874
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED AND AN EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, NEARSIGHTEDNESS AND THE IOL WAS EXCHANGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE BUSINESS OPERATIONAL MANAGER, WHO REPORTED THAT THE SURGEON'S OPINION THE CAUSE OF THE EVENT, AN UNANTICIPATED MYOPIC OUTCOME, IS UNKNOWN. THE EVENT RESOLVED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709871 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN6AD1 12244509

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention HEALON| MONARCH II HANDPIECE| MONARCH D CARTRIDGE| ANTIBIOTIC EYEDROPS| ANTIINFLAMMATORY EYE DROPS