BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1013806 · Received March 14, 2008

    Report

    Report Number
    1119421-2008-00132
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    December 21, 2007
    Report Date
    February 14, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ONE MONTH FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT'S LENS HAD ROTATED 34 DEGREES. TWO MONTHS FOLLOWING IMPLANT, THE LENS WAS REPOSITIONED. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF EVENT AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T5 10704226

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention