BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1034590 · Received April 23, 2008

    Report

    Report Number
    1119421-2008-00264
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 24, 2008
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 04/02/2008, 04/04/2008 AND 04/18/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED GLARE AND HALOS. THERE ARE TWO MFR'S DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD / HUNTINGTON SN6AD3 10758774

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other