BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1120787 · Received August 15, 2008

    Report

    Report Number
    1119421-2008-00601
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 18, 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
    MI, 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. ADD'L INFO WAS REQUESTED 07/18/2008, 07/22/2008, 07/24/2008, 07/28/2008 AND 08/06/2008 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FIVE YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED BLURRY VISION IN THE LEFT EYE. UPON EXAMINATION, THE LENS WAS NOTED TO BE CLOUDY. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF EVENT FOR THE PT IS "UNK" AND STATES THAT HE DOES NOT THINK THE EVENT IS LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 739407

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other