BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 892374 · Received August 9, 2007

    Report

    Report Number
    1119421-2007-00333
    Event Type
    Other
    Date Received
    August 9, 2007
    Date of Event
    December 1, 2006
    Report Date
    July 16, 2007
    Manufacturer
    ALCON LABORATORIES, INC/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 ARE NO SIMILAR REPORTS IN THIS LOT OF PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND MAIL ON 07/13/2007 AND BY PHONE ON 07/12/2007, 07/16/2007, 07/17/2007, 07/30/2007. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON AND FROM THE PT BY PHONE AND BY MAIL.

    Description of Event or Problem · 1

    SURGEON REPORTED A PT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY (RIGHT EYE -OD) AND IN THE FOLLOWING MONTH (LEFT EYE -OS). THE PT REPORTED HE HAS BLURRY VISION AT INTERMEDIATE DISTANCES. HE ALSO STATED HE SEES HALOS AROUND LIGHTS ON CLOUDY DAYS AND AT NIGHT IN BOTH EYES (OU). HEADLIGHTS SEEM TO BE TRIPLE IN SIZE AND HE REPORTS SEEING RINGS AROUND THEM. THE PT HAS A HISTORY OF SEEING FLOATERS, BUT FEELS THEY HAVE BECOME MORE BOTHERSOME SINCE SURGERY (ESPECIALLY OD). THE IOLS REMAIN IMPLANTED OU. MDR FOR RIGHT EYE: 1119421-2007-00332. THIS MDR IS FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTON SN60D3 951368

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other