BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1211497 · Received October 23, 2008

    Report

    Report Number
    1119421-2008-00831
    Event Type
    Other
    Date Received
    October 23, 2008
    Date of Event
    July 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN NO OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER WHICH IS FOR THE SAME PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON 09/24/2008 AND 10/06/2008 BY FAX, MAIL, AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT EXPERIENCING TEARING, PHOTOPHOBIA, AND BLURRY VISION, "LIKE THERE WAS A FILM OVER BOTH EYES", FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY OVER ONE YEAR AGO. IT WAS ALSO NOTED THAT THE LENS HAS A "THIN HAIR SPRAY-LIKE COATING OVER THE BACK SURFACE". ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH 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. SA60D3 145482

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other