BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR MULTIFOCAL TORIC

    MDR report key: 2161819 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00855
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    February 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, ONLY THE CARTON AND INSERTS WERE RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED AN INTRAOCULAR LENS (IOL) ROTATED FOLLOWING IMPLANT SURGERY. THE LENS WAS REPOSITIONED. IN A FOLLOW-UP, THE REPORTER INDICATED THAT THE PATIENT EXPERIENCED "BAD" VISION AT ALL DISTANCES. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ RESTOR MULTIFOCAL TORIC INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SND1T4 11046467

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention MONARCH CARTRIDGE D| PROVISC| ACULAR| MONARCH HANDPIECE| ISOPTOMAX