BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1172755 · Received September 18, 2008

    Report

    Report Number
    1119421-2008-00731
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    April 1, 2007
    Report Date
    August 19, 2008
    Manufacturer
    ALSON 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
    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 INFORMATION WAS REQUESTED VIA PHONE ON 08/21/2008, 09/03/2008, AND VIA FAX AND MAIL ON 08/21/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 09/18/2008.

    Description of Event or Problem · 1

    FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CONSUMER REPORTED THAT HER VISION IS WORSE THAN IT WAS BEFORE. SHE STATED SHE IS UNABLE TO READ THE BUTTONS ON HER CAR, DO COMPUTER WORK, OR THREAD ON HER SEWING MACHINE. SHE REPORTED SHE IS ALSO UNABLE TO READ BOOKS AND THE NEWSPAPER HEADLINES. CONSUMER STATED USE OF READING GLASSES DOES NOT HELP HER VISION. THE SURGEON REPORTED A LIMBAL RELAXING INCISION WAS PERFORMED ON THE PATIENT DURING SURGERY. HE STATED THE PATIENT HAS SOME UNWANTED VISUAL ABERRATIONS; HOWEVER, OUTCOME OF THE EVENT WAS "EXCELLENT". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALSON RESEARCH, LTD. / HUNTINGTON SN60D3 980696

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ECONOPRED| XIBROM| VIGAMOX