BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1291026 · Received December 19, 2008

    Report

    Report Number
    1119421-2008-01057
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    December 1, 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
    FL, US
    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. ADDITIONAL INFO WAS REQUESTED ON 12/01/2008, 12/03/2008, 12/04/2008, AND 12/12/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/12/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A PT WITH A HAZY INTRAOCULAR LENS (IOL) EIGHT YEARS FOLLOWING IMPLANT SURGERY. THE HAZY IOL WAS EFFECTING THE PT'S VISION. IN A FOLLOW-UP, THE SURGEON STATED THAT TO THIS KNOWLEDGE THERE WAS NOT A PROBLEM WITH THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA30BA 577911

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Other