BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1804199 · Received August 11, 2010

    Report

    Report Number
    1119421-2010-00884
    Event Type
    Other
    Date Received
    August 11, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "BLURRED VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT HE WAS VERY DISAPPOINTED WITH HIS RESULTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER STATED HE HAD A HISTORY OF A MOTOR VEHICLE ACCIDENT (MVA) IN WHICH HE SUSTAINED UNK EYE DAMAGE. HE HAD BEEN WEARING SOFT CONTACT LENSES (SCL) SINCE HIS MVA AND WANTED TO STOP WEARING HIS SCLS. HIS SURGEON RECOMMENDED AN IOL IMPLANT. FOLLOWING THE IOL IMPLANT SURGERY, THE CONSUMER REPORTED HE HAS BLURRED VISION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60BM 942009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other