BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1211514 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00818
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGDON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 09/19/2008 AND 10/03/2008 BY PHONE, FAX, AND MIAL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS FOUND TO BE OFF AXIS. A SUTURE WAS PLACED AT THE TIME SURGERY. THE SURGEON FELT THAT THIS COULD BE PRODUCING SOME OF THE POSTOPERATIVE ASTIGMATISM THAT HE WAS OBSERVING. AT A FOLLOW-UP VISIT, TOPOGRAPHY SHOWED STEEPNESS IN THE AREA OF THE SUTURE. THE SUTURE WAS REMOVED AND THE PATIENT WAS ASKED TO RETURN FOR A CHECK-UP. THE SURGEON STATED THAT THE PATIENT IS HAPPY WITH HER VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./HUNTINGDON SN60T5 10826350

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other