BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2599451 · Received June 1, 2012

    Report

    Report Number
    1119421-2012-00715
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 4, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD¿L INFO WAS REQUESTED ON 05/04/2012 AND 05/30/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTED THE LENS WAS CLOUDY AND THE PT¿S VISION IS AFFECTED. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON MA60AC 12049240

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other DEXAMETHASONE| GENTAMICIN