BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1101750 · Received August 7, 2008

    Report

    Report Number
    1119421-2008-00578
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 8, 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 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. THIS REPORT WAS MAILED TO FDA ON: 08/07/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, PATIENT REPORTED BLURRY VISION. THE IOL WAS REPORTED TO BE OPACIFIED. THE SURGEON ALSO REPORTED THAT THERE WERE DEPOSITS ON THE IOL AND A YAG WAS PERFORMED; HOWEVER, IT DID NOT RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60BM 705821

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention