BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1414867 · Received June 26, 2009

    Report

    Report Number
    1119421-2009-00617
    Event Type
    Other
    Date Received
    June 26, 2009
    Date of Event
    June 8, 2009
    Report Date
    May 29, 2009
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 05/29/2009, 06/02/2009, 06/17/2009, 06/19/2009, 06/22/2009, AND 06/24/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/18/2009. THIS REPORT WAS MAILED TO FDA ON: 06/26/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING VISION PROBLEMS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE IOL HAD BEEN IMPLANTED UPSIDE DOWN. THE PATIENT REPORTED HEADACHES, TROUBLE FOCUSING WHEN USING BOTH EYES, POOR NEAR VISION, SENSITIVITY TO LIGHT, AND REFLECTIONS SEEN BY OTHERS FOLLOWING HER IOL IMPLANT SURGERY. THE IMPLANTING SURGEON REPORTED THAT POSTERIOR CAPSULE OPACIFICATION HAD BEEN PREVIOUSLY NOTED. IN A FOLLOW UP, THE IMPLANTING SURGEON REPORTED THE EVENT SHOULD RESOLVE WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 10755094

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other VISCOELASTIC