BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1375254 · Received February 20, 2009

    Report

    Report Number
    1119421-2009-00132
    Event Type
    Other
    Date Received
    February 20, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 21, 2009
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULT 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 BY FAX AND EMAIL ON 01/22/2009. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/29/2009. THIS REPORT WAS MAILED TO FDA ON: 02/20/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE SURGEON REPORTED THE OUTCOME OF THE EVENT AS "POOR". IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN60WF 10850050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other