BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1534740 · Received November 18, 2009

    Report

    Report Number
    1119421-2009-01088
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    July 28, 2009
    Report Date
    October 19, 2009
    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
    KS, 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 ON 10/19/2009, 10/22/2009, 10/23/2009 AND 11/06/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 11/06/2009. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS NOTICED THAT WHILE READING SHE EXPERIENCES A CONTINUOUS FLICKERING OF HER EYE, BLURRY VISION AND EYE PAIN. IN A FOLLOW UP, THE SURGEON REPORTED THAT HE DOES NOT FEEL THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE PT DOES HAVE SOME MILD POSTERIOR CAPSULE OPACIFICATION WHICH THE SURGEON FEELS MAY BE CONTRIBUTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10751266

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other AMVISC PLUS| DRY EYE TREATMENT - TYPE UNK