BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1960260 · Received January 6, 2011

    Report

    Report Number
    1119421-2010-01500
    Event Type
    Other
    Date Received
    January 6, 2011
    Date of Event
    October 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THE TIME. IT WILL BE REASSESSED UPON SIMPLE RECEIPT. ADDITIONAL INFO WAS REQUESTED ON 12/10/2010, 12/13/2010, 12/17/2010, AND 12/22/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS HOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 12/07/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON'S OFFICE REPORTED A PT EXPERIENCING BLURRED VISION, GLARE, AND A SHADOW IN HER PERIPHERAL VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other