BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1941807 · Received December 8, 2010

    Report

    Report Number
    1119421-2010-01362
    Event Type
    Other
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 8, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 11/09/2010, 11/12/2010 AND 11/15/2010 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED 11/12/2010 AND 11/17/2010 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING STARBURSTS AT NIGHT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE WEARS A CONTACT LENS WHICH YIELDS "PERFECT" DISTANCE VISION AT NIGHT. HOWEVER, SHE IS UNABLE TO READ WHEN WEARING THE CONTACT LENS. IN A FOLLOW UP, THE SURGEON'S TECHNICIAN STATED THE PT'S SYMPTOMS ARE NOT LENS RELATED. 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 10938107

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other