BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1552228 · Received December 4, 2009

    Report

    Report Number
    1119421-2009-01151
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    June 11, 2009
    Report Date
    September 30, 2009
    Manufacturer
    ALCON RESEARCH LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/02/2009, 10/05/2009, 10/07/2009, 10/22/2009, AND 10/27/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/05/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING MYOPIC SURPRISES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE IOLS WERE EXCHANGED FOR SAME MODEL, DIFFERENT POWER LENSES. IN A FOLLOW-UP, THE SURGEON REPORTED THE PATIENT HAS "SHORT EYES" AND THAT MOST LIKELY, AN ANTERIOR LENS POSITION THAT WAS NOT ACCOUNTED FOR BY ANY FORMULA CAUSED THE UNEXPECTED MYOPIA. HE REPORTED THAT THE PATIENT IS DOING WELL POST-EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD. SN6AD1 10870169

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention VISCOAT