BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1914370 · Received November 18, 2010

    Report

    Report Number
    1119421-2010-01273
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 19, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. 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. ADDITIONAL INFO WAS REQUESTED ON 10/19/2010 AND 10/20/2010 BY PHONE, FAX AND MAIL. ADD'L INFO WAS OBTAINED FROM A NOTE FROM THE SURGEON'S OFFICE. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. PT (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, IT WAS REPORTED THAT THE EVENT WAS NOT A SURPRISE AND THE PT HAS ASTIGMATISM. NO FURTHER INFO IS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other