BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1902350 · Received November 11, 2010

    Report

    Report Number
    1119421-2010-01235
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    May 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ALCON REASEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    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. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS VISION WAS BLURRY AND NOT AS GOOD AS BEFORE THE PROCEDURE. THE CONSUMER REPORTED A LASER PROCEDURE HAD BEEN PERFORMED DUE TO A QUESTION AS TO WHETHER THE LENS WAS SITTING CORRECTLY. FOLLOWING THE LASER PROCEDURE, THE CONSUMER WAS STILL DISAPPOINTED WITH HIS RESULT. THE CONSUMER REPORTED HE WAS REFERRED TO ANOTHER PHYSICIAN AND WAS TOLD HE HAD SOME MINOR MACULAR DEGENERATION IN HIS EYE, BUT NOT SUFFICIENT TO BE OF CONCERN. THE CONSUMER'S OPTOMETRIST HAS RECOMMENDED A TRIAL CONTACT LENS SINCE HIS VISION HAS CHANGED NOTICEABLE. AT THAT VISIT, THE OPTOMETRIST TOLD HIM HIS LENS WAS SITTING "WELL". THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE, BUT REPORTED THE PT HAD SIGNIFICANT CO-MORBIDITIES THAT WERE BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON REASEARCH, LTD./HUNTINGTON SN60WS 10978856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention